Continuous anesthesia nerve conduction apparatus, system and method thereof

ABSTRACT

The invention generally relates to a continuous anesthesia nerve conduction apparatus and method thereof, and more particularly to a method and system for use in administering a continuous flow or intermittent bolus of anesthetic agent to facilitate a continuous or prolonged nerve block. In one embodiment, the apparatus includes a sheath having a proximal end, a distal end and at least one lumen extending from the proximal end to the distal end. The sheath also includes an embedded conductive element for transmitting an electrical signal from a proximal portion of the sheath to a distal portion of the sheath. A cannula is arranged in the at least one lumen of the sheath and has a distal end protruding from a distal portion of the sheath. The cannula is electrically coupled to at least a portion of the embedded conductive element and is configured to provide nerve stimulation.

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/006,962, filed on Sep. 23, 2013, and also claims the benefitunder 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No.61/724,539, filed on Nov. 9, 2012; U.S. patent application Ser. No.14/006,962 is the National Stage of International Application No.PCT/US2012/038504, filed May 18, 2012, which claims the benefit under 35U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/487,555,filed on May 18, 2011, and U.S. Provisional Patent Application No.61/532,316, filed on Sep. 8, 2011; each of these applications are herebyincorporated by reference for all purposes as if fully set forth herein.

BACKGROUND OF THE INVENTION Field of the Invention

The invention generally relates to a continuous anesthesia nerveconduction apparatus, system and method thereof, and more particularlyto a method and system for use in administering a continuous flow orintermittent bolus of anesthetic agent to facilitate a continuous orprolonged nerve block.

Discussion of the Related Art

Currently, regional anesthesia techniques have been employed toselectively anesthetize a nerve or groups of nerves to provide painrelief to patients following a medical-surgical procedure or trauma.Anesthetic agents, such as local anesthetic medication, are administeredin close proximity to nerve(s) that innervate the affected region of thebody. These nerves are located deep within the tissues and a hollow borehypodermic needle is used to deliver the anesthetic medication to thenerve(s).

In continuous regional anesthetic procedures, in lieu of a needle, acatheter and needle are inserted adjacent to the nerve(s). The needle isremoved after the catheter placement, and the catheter may be left inposition for several days so that anesthetic medication can berepeatedly or continuously delivered to the targeted nerve(s). Thesenerve blocks are only efficacious if the anesthetic medication can bedelivered consistently in close enough proximity to the nerve(s) so asto impart its action on the nerve(s).

U.S. Pat. No. 5,976,110 discloses an epidural needle that can be coupledto a nerve stimulator. The nerve stimulator is configured to provide anelectrical current that activates the targeted nerve(s) as the needlegets into close proximity of the nerve(s). An epidural catheter isinserted through the lumen of the epidural needle and advanced until thedistal tip extends several centimeters past the distal tip of theneedle. The epidural catheter is placed without any visualization aidand is assumed to be in close enough proximity to the targeted nerve dueto the needle tip position.

U.S. Pat. No. 6,456,874 discloses an epidural catheter configured toemit an electrical impulse. Placement of the catheter tip andconfirmation of the catheter tip placement is obtained by stimulatingthe targeted nerve(s) via the nerve stimulator.

In addition to the use of peripheral nerve stimulation for nervelocalization, ultrasound imaging has become a common method to positionneedles and catheters in close proximity to nerve(s).

The related art has a number of disadvantages. The ultrasound probe isbest managed by the operator of the needle and/or catheter. As such, tomaintain real-time imaging, one of the operator's hands needs to beoccupied handling the ultrasound transducer. However, the procedure isdifficult with the related art devices as both hands are required foradvancing a catheter through the needle. Therefore, during thisprocedure the ultrasound probe must be put down and the visualization atthat point is lost.

Alternatively, another clinician is required or some sort of mechanicalholding means may be utilized. These alternatives both havedisadvantages. The ultrasound image is a two-dimensional image with animage plane of typically less than one millimeter. The mechanicalholding devices, i.e., an articulating probe holder often is noteffective because patient movement can cause the image to distort ordeviate, thereby preventing reliable real-time imaging of the catheterexiting the needle and also preventing visual confirmation of theposition of the catheter tip. Moreover, the related art catheter devicesfrequently employ Touhy tipped needles that tend to cause the catheterto curve away from the tip of the needle and out of the two-dimensionalvisualization plane as the catheter exits the needle. Therefore, imagesof the needle with the catheter exiting the needle are not typicallyobtained and the relationship to the targeted nerve(s) is notconclusively obtained.

Another disadvantage of the related art is the need for two hands tomanage the catheter advancement, as both hands require sterile glovesand sterile procedural adherence. Thus, the ultrasound device will needto be sterile, which requires additional setup such as sterile sleevesfor the ultrasound probe, sterile ultrasound gel, extensive draping, andadditional personnel. This additional setup adds to the complexity,inefficiency, timeliness, and cost of clinicians performing thistechnique.

The related art catheters themselves also have disadvantages. Forexample, in order for the needle to be withdrawn while trying tomaintain the catheter in place, the catheter needs to be about twice thelength of the needle. This added length makes the catheter unwieldy,expensive, and difficult to use. The catheter also requires a lubriciousexterior so that it will easily slide through the needle. The lubriciousexterior of the catheter makes it difficult to adhere to the skin of thepatient, which leads to easy dislodgement from its position adjacent tothe nerve(s).

In addition, passing the catheter through the lumen of a large boreneedle, the catheter's diameter is such that it is smaller than that ofthe puncture made by the needle through the tissue. The catheterdiameter size being smaller than the needle can lead to leakage ofmedication at the insertion site during medication infusion, increasingthe chance of catheter dislodgement.

There is a need for an improved continuous anesthesia nerve conductionapparatus, system and method that substantially obviates one or more ofthe problems due to limitations and disadvantages of the related art.

SUMMARY OF THE INVENTION

Accordingly, the invention is directed to continuous anesthesia nerveconduction apparatus, system and method that substantially obviates oneor more of the problems due to limitations and disadvantages of therelated art.

An advantage of the invention is that the procedure may be performed byone proficient in the art in approximately the same time or less than ittakes to perform a single-injection nerve block with a needle alone. Inmost cases, the procedure may be performed in less than approximatelyten minutes.

Another advantage of the invention is that the procedure does notrequire a full sterile setup, thereby reducing the time of theprocedure.

Still another advantage of the invention is to provide an apparatus andmethod for performing continuous nerve blocks under real-time ultrasoundguidance that may be performed with a single hand by one operator.

Yet another advantage of the invention is to provide an apparatus andmethod that allows for easy handling with secure fixation to preventdislodgement and minimize leakage during infusion.

Still yet another advantage is to provide an apparatus and method thatallows for a single operator to easily and efficiently place acontinuous nerve conduction catheter while simultaneously visualizingthe catheter placement under ultrasound guidance, e.g., with markings ormarkers as described herein.

Still another advantage is to provide an apparatus and method thatallows for peripheral nerve stimulation capability to be performedsimultaneously with visualization and with one handed operation.

Another advantage is to provide peripheral nerve stimulation emittingfrom a needle and/or the catheter. The catheter stimulation may be usedfor secondary confirmation, if needed. The nerve stimulation can also beutilized via a single electrical connection at or near a hub of thecatheter.

Still another advantage is to provide an apparatus and method thatpermits a fast, cost efficient, and minor labor intensive process,thereby making continuous nerve conduction pain relief accessible formore patients.

Yet another advantage is to provide a catheter with a lateral portconfigured to minimize occlusion rate when compared to a catheter withonly a distal opening.

Still another advantage is to provide a catheter with a preformedresilient distal portion to allow the distal portion of the catheter tobe positioned at least partially around a nerve, thereby permittingdelivery of a pharmacological agent more effectively around the entirenerve as compared to infusion from a straight catheter that ispositioned at a single point. In a preferred embodiment, at least onelateral port is positioned near or on an apex of a curved portion of thecatheter.

Yet another advantage is to provide a catheter with a thickened orroughened proximal segment of catheter, thereby minimizing leakage ofinfused medication by wedging the catheter into the skin opening at theinsertion site. Leakage of medication tends to loosen the dressing andincrease the chance of accidental dislodgement.

Still yet another advantage is to stimulate a needle while using thecatheter as the insulator. This permits a single attachment point forthe nerve stimulator while reducing procedural steps and also simplifiesmanufacturing by eliminating the redundant insulating coating for thestimulating needle.

Yet still another advantage is to provide a guidewire for catheterpositioning. The guidewire may include a pre-shaped distal tip configureto allow a catheter to track this geometry. Typically, a catheter doesnot readily move into the pre-determined position because of a lack ofspace caused by tissue surrounding the nerve(s) and utilizing aguidewire can eliminate this problem. In addition, a directionalguidewire may be utilized. The directional guidewire is known in the artand may be smaller and stiffer which permits easier positioning aroundthe nerve(s) in a curved orientation and would then allow for thecatheter to follow the tract of the guidewire. Moreover, an integratedguidewire with a needle may be utilized. This type of configurationallows for single handed deployment of guidewire by advancing the tab onthe needle hub, also reducing procedural steps by not having to detachthe syringe before advancing guidewire. This can also be a methodologydifferentiation.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be apparent from thedescription, or may be learned by practice of the invention. Theobjectives and other advantages of the invention will be realized andattained by the structure particularly pointed out in the writtendescription and claims hereof, as well as the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the present invention, as embodied and broadly described, theapparatus includes a sheath, also referred to as a catheter having aproximal end, a distal end and at least one lumen extending from theproximal end to the distal end. In one embodiment, the sheath caninclude an embedded conductive element, e.g., wire, for transmitting anelectrical signal from a proximal portion of the sheath to a distalportion of the sheath. A cannula, e.g., needle or introducer, isarranged in at least one lumen of the sheath and sized such that adistal end portion extends past a distal end portion of the sheath. Thecannula can be electrically coupled to at least a portion of theembedded conductive element and is configured to provide nervestimulation.

In another aspect of the invention, a method for administering acontinuous flow or intermittent bolus of anesthetic agent to facilitatea continuous or prolonged nerve block includes providing a sheath havinga lumen extending from a proximal end to a distal end. The sheathincludes an embedded conductive element for transmitting an electricalsignal from a proximal portion of the sheath to a distal portion of thesheath. In another embodiment, the sheath provides for insulation of theelectrical signal along the shaft of the cannula.

The method further includes providing a cannula into at least one lumenof the sheath. The method further includes connecting a syringeconfigured to administer a pharmacological agent to the proximal end ofthe cannula and coupling an electrical signal generator to the embeddedconductive element or the proximal portion of the needle. Next, thecannula and sheath are inserted simultaneously into the patient as asingle unit. The method includes locating at least one nerve of thepatient with at least one of an electric signal generated from theelectrical signal generator and/or an active imaging device. Next, uponlocation of the nerve, a pharmacological agent is administered to thenerve after which advancing and positioning the sheath off of thecannula with a single hand of a single user. If necessary, a guidewirecan be deployed to direct the catheter into a curved position around thenerve(s). Alternatively, the catheter has a preformed memory shape andupon removal of the cannula, the sheath curves to the preformed memoryshape.

Yet another embodiment of the invention is directed towards a kit, e.g.,a medical package. The kit includes an apparatus for administering acontinuous flow or intermittent bolus of anesthetic agent to facilitatea continuous or prolonged nerve block and directions for use. The kitmay also optionally include a pump for administering a pharmacologicalagent, e.g., a disposable infusion pump.

Yet another embodiment of the invention is directed towards a kit,wherein the kit includes sterilized and recycled apparatuses, such as arecycled pump, e.g., infusion pump.

Yet another embodiment of the invention is directed to a method ofintroducing fluid to a nerve or nerve bundle of a patient. The methodincludes the steps of providing an introducer through a lumen of thecatheter such that the introducer protrudes out the distal tip of thecatheter. The method also includes piercing the skin of the patient withthe introducer and catheter and advancing the introducer and catheterthrough the patient's tissue to a nerve bundle. Upon location of thenerve via imaging and/or electrical stimulation removing the introducerfrom the catheter. The distal end portion of the catheter is now locatedin proximity of the nerve bundle and fluid is introduced to the nervebundle through the catheter, e.g., a nerve block.

Yet another embodiment of the invention is directed to a system fordelivery of a fluid to a nerve bundle of a patient. The system includesa fluid pump, a length of tubing securable to said pump, an introducer,and a catheter. The introducer fits within the catheter. The catheter,pump, tubing, and introducer are provided together as a kit. Eachcomponent of the kit is sterilized.

Yet another embodiment of the invention is directed to a device fordispensing fluid to a patient. The device includes a catheter and anintroducer. The introducer fits within a lumen of the catheter and isutilized as a system for insertion into the patient. The catheter isconfigured to be connected to a pump. The pump is compact and portableand configured for dispensing a liquid under pressure at a substantiallyconstant flow rate.

In one embodiment, the pump includes an elongated, substantiallycylindrical support member, an elongated elastic sleeve device mountedon and sealingly secured at fixed spaced longitudinal positions on saidsupport member for defining a pressure reservoir for holding a liquid ina pressurized state for dispensing therefrom. The pump also includes asubstantially spherical rigid housing formed of like half-shells hingedtogether for removably containing a support member and a pressurereservoir for enabling said pressure reservoir to expand naturally andfor confining said reservoir to fill concentrically about said supportmember. The pump includes an inlet device for introducing a liquid intosaid elastic pressure reservoir and an outlet device for dispensingliquid from said pressure reservoir to a selected site.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory, andare intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description serve to explain the principles of theinvention.

In the drawings:

FIG. 1 illustrates an operational systematic view of a continuousanesthesia nerve conduction system according to an embodiment of theinvention;

FIG. 2A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 2B illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus shown in FIG. 2A;

FIG. 3A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 3B illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus shown in FIG. 3A;

FIG. 3C illustrates an enlarged view of the distal section of theconduction apparatus according to FIG. 3A;

FIG. 4 illustrates an enlarged view of a distal section of a conductionapparatus according to another embodiment of the invention;

FIG. 5 illustrates an enlarged view of a distal section of a conductionapparatus according to another embodiment of the invention;

FIG. 6A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 6B illustrates an enlarged view of a distal portion of thecontinuous anesthesia nerve conduction apparatus of FIG. 6A in variousconfigurations;

FIG. 7 illustrates an infusion pump;

FIG. 8 illustrates a cross-sectional view of the infusion pump of FIG.7;

FIG. 9 illustrates an infusion pump;

FIG. 10 illustrates a cross-sectional view of the infusion pump of FIG.9;

FIG. 11 illustrates an infusion pump;

FIG. 12 illustrates a top view of the infusion pump of FIG. 11, withoutthe cover;

FIG. 13 illustrates a cross-sectional view of an infusion pump in acollapsed configuration;

FIG. 14 illustrates a cross-sectional view of the infusion pump of FIG.13 in the inflated configuration;

FIG. 15A illustrates a distal portion of a catheter according to anotherembodiment of the invention;

FIG. 15B illustrates a distal portion of a catheter according to anotherembodiment of the invention;

FIG. 16 illustrates a single handed catheter advancing device accordingto another embodiment of the invention;

FIG. 17A illustrates a single handed catheter advancing device accordingto another embodiment;

FIG. 17B illustrates a perspective view of the single handed catheteradvancing device of FIG. 17A;

FIG. 17C illustrates a perspective view of a single handed catheteradvancing device illustrated in FIG. 17A with a catheter;

FIG. 18 illustrates the single handed catheter advancing device of FIG.17C in use;

FIG. 19A illustrates an embodiment of a solid introducer according toanother embodiment of the invention;

FIG. 19B illustrates a continuous anesthesia nerve conduction apparatusincluding solid introducer of FIG. 19A in a catheter according toanother embodiment of the invention;

FIG. 20 illustrates a continuous anesthesia nerve conduction apparatusincluding a hollow introducer in a catheter according to anotherembodiment of the invention;

FIG. 21 illustrates an embodiment of a guidewire according to anotherembodiment of the invention;

FIG. 22A illustrates a continuous anesthesia nerve conduction apparatusincluding a hollow introducer in a catheter with a sleeve according toanother embodiment of the invention;

FIG. 22B illustrates a continuous anesthesia nerve conduction apparatusincluding a guidewire in a catheter with a sleeve according to anotherembodiment of the invention;

FIG. 23 illustrates a continuous anesthesia nerve conduction apparatusaccording to another embodiment of the invention;

FIG. 24 illustrates an insert for connection of an electrical nervestimulator to a cannula according to another embodiment of theinvention;

FIG. 25A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention infirst orientation;

FIG. 25B illustrates the continuous anesthesia nerve conductionapparatus of FIG. 25A in a second orientation;

FIG. 25C illustrates a guidewire according to another embodiment of theinvention;

FIG. 25D illustrates a guidewire according to another embodiment of theinvention;

FIG. 26A illustrates a continuous anesthesia nerve conduction apparatusaccording to another embodiment of the invention;

FIG. 26B illustrates a cross-sectional view of a distal portion of thecontinuous anesthesia nerve conduction apparatus according to FIG. 26A;

FIG. 27A illustrates a continuous anesthesia nerve conduction apparatusaccording to another embodiment of the invention;

FIG. 27B illustrates a cross-sectional view of a distal portion of thecontinuous anesthesia nerve conduction apparatus according to FIG. 27A;

FIG. 28A illustrates a distal portion of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 28B illustrates a distal portion of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 29A illustrates an exemplary view of an apparatus according to anembodiment of the invention;

FIG. 29B illustrates an exemplary view of a cannula according to theapparatus of FIG. 29A;

FIG. 29C illustrates an exemplary view of a catheter according to theapparatus of FIG. 29A;

FIG. 29D illustrates an exemplary view of a catheter according toanother embodiment of the invention;

FIG. 29E illustrates an exemplary view of a catheter according toanother embodiment of the invention;

FIG. 30A illustrates a perspective view of a cannula according toanother embodiment of the invention;

FIG. 30B illustrates a top-down view of the cannula according to FIG.30A;

FIG. 30C illustrates an enlarged view of a distal end portion of thecannula according to FIG. 30A;

FIG. 31A illustrates a cross-sectional view of a cannula according toanother embodiment of the invention;

FIG. 31B illustrates a proximal end view of the cannula of FIG. 31A;

FIG. 31C illustrates an exploded view of a hub portion of the cannula ofFIG. 31A;

FIG. 32A illustrates an exemplary view of a catheter according toanother embodiment of the invention;

FIG. 32B illustrates an enlarged view of section B-B of the catheter ofFIG. 32A;

FIG. 32C illustrates an enlarged cross-sectional view of a distal endportion of the catheter of FIG. 32A;

FIG. 32D illustrates a proximal end view of the catheter of FIG. 32A;

FIG. 32E illustrates an enlarged proximal view of the catheter of FIG.32A;

FIG. 33 illustrates an exemplary view of a catheter according to anotherembodiment of the invention;

FIG. 34A illustrates a top view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 34B illustrates a bottom view of a continuous anesthesia nerveconduction apparatus according to FIG. 34A;

FIG. 34C illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus according to FIG. 34A;

FIG. 35A illustrates a perspective view of an extension tubing setaccording to another embodiment of the invention;

FIG. 35B illustrates a side view of the extension tubing set of FIG.35A;

FIG. 36A illustrates an enlarged view of a portion of a continuousanesthesia nerve conduction apparatus according to another embodiment ofthe invention;

FIG. 36B illustrates a graph of an interference fit according to FIG.36A;

FIG. 37A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention;

FIG. 37B illustrates a catheter according to another embodiment of theinvention;

FIG. 37C illustrates an anti-restriction member according to anotherembodiment of the invention;

FIG. 37D illustrates a catheter according to another embodiment of theinvention;

FIG. 37E illustrates a catheter according to another embodiment of theinvention;

FIG. 37F illustrates a catheter according to another embodiment of theinvention;

FIG. 37G illustrates a catheter according to another embodiment of theinvention;

FIG. 38 illustrates a kit according to an another embodiment of theinvention;

FIG. 39 illustrates exemplary supplies of a single sterile devicepackage according to an example of the invention;

FIG. 40 illustrates the localized sterilization of a patient's skinaccording to an example of the invention;

FIG. 41 illustrates the anesthetizing of a patient, while simultaneouslyimaging the patient according to an example of the invention;

FIG. 42 illustrates an operator inserting the needle and catheter intothe patient according to an example of the invention;

FIG. 43 illustrates an operator hydrodissecting the tissue of a patientaccording to an example of the invention;

FIG. 44 illustrates the positioning of the catheter, whilesimultaneously imaging the patient according to an example of theinvention;

FIG. 45 illustrates injecting a pharmacological agent into a patientthrough the catheter according to an example of the invention;

FIG. 46 illustrates attaching tubing to the catheter hub according to anexample of the invention; and

FIG. 47 illustrates the catheter being secured to the patient accordingto an example of the invention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the exemplaryembodiments illustrated in the drawing(s), and specific language will beused to describe the same.

Appearances of the phrases an “embodiment,” an “example,” or similarlanguage in this specification may, but do not necessarily, refer to thesame embodiment, to different embodiments, or to one or more of thefigures. The features, functions, and the like described herein areconsidered to be able to be combined in whole or in part with oneanother as the claims and/or art may direct, either directly orindirectly, implicitly or explicitly.

As used herein, “comprising,” “including,” “containing,” “is,” “are,”“characterized by,” and grammatical equivalents thereof are inclusive oropen-ended terms that do not exclude additional unrecited elements ormethod steps unless explicitly stated otherwise.

In order to more fully appreciate the present disclosure and to provideadditional related features, the following references are incorporatedherein by reference in their entireties:

(1) U.S. Pat. No. 5,100,390 by Lubeck, et al., which discloses a needlehereafter referred to as a metal cannula is of thin-walled constructionand designed with a solid noncutting pencil point possessing a tip withan elliptical side port located not more than 1 (one) cannula OuterDiameter (O.D.) length from the tip. Via a hollow internal channel theaxial length of the cannula is capable of guiding an inserted catheterthrough the cannula for projection laterally out of the cannula forsubsequent indwelling placement of the introduced catheter upon removalof the cannula. The sideport is placed on the angled surface of thedeveloping point so that it coincides with the angle of the pencilpoint. The elliptical sideport has a machined and polished roundedinternal edge intersecting with the external surface. The constructionof the cannula combining a large diameter with a pencil point and thelocation of an opening at the tip permits safe introduction of a spinalcatheter into the subarachnoid space with minimum damage to tissues ormembranes by either the cannula or a catheter exiting the sideport. Thecannula is fitted with an obturator which coincides with the shape ofthe internal lumen of the cannula where the obturator tip curves upwardto occlude the opening of the cannula sideport. The cannula of thepresent invention has application to subarachnoid and epidural regionalanesthesia and pain management procedures. The present invention isdesigned preferably as a large gauge needle (17 to 21 gauge) so that itwill accept insertion of a large flexible catheter (20 to 22 gauge indiameter) for indwelling placement.

(2) U.S. Pat. No. 5,364,373 by Waskonig, et al., which discloses anepidural cannula for local anesthesia having a cannula point with anadjacent lateral opening parallel to the longitudinal axis of thecannula. The cannula has a cross-sectional enlargement spaced from thepoint and having an area directed toward the point that forms an anglegreater than 30 degrees relative to the longitudinal axis of thecannula.

(3) U.S. Pat. No. 5,817,017 by Young, et al., which discloses cathetersand other medical devices include a non-metallic member havingparamagnetic ionic particles fixedly incorporated therethrough in orderto provide enhanced detectability when viewed by magnetic imagingregardless of the orientation of the non-metallic member in the magneticfield. Catheters are usually formed from polymeric tubing, and theparamagnetic ionic particles are usually formed from paramagnetic ionsincorporated with water or other proton-donating fluid into carrierparticles, such as zeolites, molecular sieves, clays, synthetic ionexchange resins, and microcapsules. Catheters and other medical devicesinclude a non-metallic member having small iron and/or superparamagneticparticles fixedly incorporated therethrough or thereover in order toprovide enhanced detectability when viewed by magnetic imaging.Catheters are usually formed from polymeric tubing, and the iron and/orsuperparamagnetic particles at or near the surface of the catheterinteract with the water protons of the surrounding patient's body toprovide image enhancement regardless of the orientation of the polymericor other non-metallic material in the magnetic field.

(4) U.S. Pat. No. 5,843,048 by Gross which discloses an epidural needlethrough which an epidural catheter may be threaded for administeringliquid anesthesia into the epidural space, the needle having a curveddistal end, the tip of the needle distal to the opening in the needleshaft being substantially planar at an angle of 80.degree.-100.degree.relative to the curved longitudinal axis of the needle shaft, the needletip being characterized as being faceted so as to retard inadvertentpassage of the needle tip through the dura mater of a patient while atthe same time retaining the sharp cutting edges common to a likeepidural needle which has not had its tip so treated.

(5) U.S. Pat. No. 5,871,470 by McWha which discloses a combined spinalepidural needle set including an epidural needle with an overall length,an open distal end and a proximal end with a hub. The epidural needlehas a hollow bore therethrough having an inside diameter. The set of theinvention includes a spinal needle with an overall length greater thanthe length of the epidural needle, a pointed distal end, a proximal endwith a hub and a hollow passage therethrough. The spinal needle has anoutside diameter less than the inside diameter of the bore of theepidural needle. The spinal needle is slidably disposed for movementwithin the epidural needle between a position wherein the distal pointof the spinal needle is substantially coincident with the open distalend of the epidural needle and at least one position wherein the distalpoint of the spinal needle projects beyond the open distal end of theepidural needle. The hubs of the epidural needle and the spinal needleeach include an adjustable engagement for preselecting the position ofthe distal point of the spinal needle with respect to the open distalend of the epidural needle.

(6) U.S. Pat. No. 8,298,208 by Racz which discloses methods forinstalling a flexible spinal needle assembly and methods of delivering afluid may include inserting a distal end of a flexible spinal needleassembly into a subject and, thereafter, disposing an anti-restrictionmember at least partially within an inner flow path of the flexiblespinal needle to substantially prevent fluid occlusion caused by bendingor kinking of the flexible spinal needle.

(7) U.S. Patent Application Publication No. 2006/0206055 by Ice whichdiscloses an epidural injection needle with a larger-gauge proximalshaft that tapers in close proximity to a smaller-gauge distal tip. Aconventional stylet of suitable material is employed to stiffen theneedle and to prevent material from entering the needle duringinsertion. Wings can be fitted to facilitate manual guidance of theneedle. The short-tapered design provides an epidural injection needlehaving a shaft large and stiff enough so that it can be reliably guidedto the epidural space but also having a small tip which minimizes traumato blood vessels, nerves, and other tissues that may be inadvertentlypunctured during the procedure. This enables epidural injections to besafer for patients than those utilizing commercially available needlesor prior-art designs.

(8) U.S. Patent Application Publication No. 2011/0112511 by Singer whichdiscloses a method and apparatus for administering liquid anestheticsaround peripheral nerves, in order to perform surgery or to relievepost-operative pain. The apparatus includes a regional anesthetic needlewith an overlying catheter. The needle is hollow and has a blunt end sothat it does not penetrate or damage a nerve or blood vessel. A stiffcatheter covers the needle up to a side hole in the needle that allowsliquid anesthetic to be injected through the needle in a forwarddirection. The needle can be removed by leaving the catheter in placewithout disturbing the location of the catheter.

(9) U.S. Patent Application Publication No. 2011/0201930 by Guzman whichdiscloses a procedure and kit are provided for performing anultrasound-guided transversus abdominis plane (TAP) procedure. Thepatient's abdomen is scanned with an ultrasound probe to identify andmark the external oblique, internal oblique, and TAP. An introducersheath is placed over a fluid delivery needle such that the distal endof the needle extends beyond the distal end of the sheath, the needlehaving echogenic properties for ultrasound imaging. The needle andsheath are ultrasonically guided into the TAP. A local anesthetic orsaline/anesthetic combination is injected through the needle to create aliquid pool in the TAP. The needle is removed from the sheath whilemaintaining the sheath within the TAP and a catheter is subsequentlyadvanced through the sheath and into the pooled liquid in the TAP. Thesheath is withdrawn while maintaining the catheter located within theTAP. A catheter is connected to a source of local anesthetic forproviding a defined volume of anesthetic to the catheter site at acontrolled delivery rate.

(10) U.S. Patent Application Publication No. 2012/0059308 by Hsu whichdiscloses an anesthetic nerve block catheter and methods of using theanesthetic nerve block catheter to perform a nerve block or continuousnerve block procedure are disclosed.

(11) U.S. Patent Application Publication No. 2012/0232389 by Guzmanwhich discloses an apparatus for administering certain nerve blocksincludes a sheath constructed from a flexible ultrasound echogenicmaterial, a more rigid introducer/dilator for introducing the sheathinto the patient, and an ultrasound echogenic catheter for insertingthrough the sheath once the distal end of the sheath is in placeadjacent the nerve(s) to be blocked and the introducer/dilator has beenwithdrawn. The catheter has provisions at its proximal end forconnecting to a source of local anesthetic. Methods for use of thisapparatus are also described.

Aspects of the invention relate to novel medical apparatuses and methodsfor placement of a continuous nerve conduction catheter for prolongedneural blockage in the area of providing patients with pain relief. Theapparatus can be placed with minimally involved methodology thatrequires only a single operator, particularly when assisted byultrasound guidance, allowing for continuous visualization or by othermeans known in the art.

In one embodiment, the apparatus includes a sheath having a proximalend, a distal end and at least one lumen extending from the proximal endto the distal end. The terms sheath and catheter are usedinterchangeably throughout the specification. The sheath may alsoinclude an embedded conductive element for transmitting an electricalsignal from a proximal portion of the sheath to a distal portion of thesheath. The sheath may be reinforced or not reinforced in any of theembodiments of the invention. A cannula or introducer is arranged in atleast one lumen of the sheath and has a distal end protruding from adistal portion of the sheath. The terms cannula, needle, and introducerare used interchangeably throughout the specification. The cannula iselectrically coupled to at least a portion of the embedded conductiveelement and may be configured to provide nerve stimulation independentlyor in conjunction with the sheath.

The cannula may include a sharp tip, a short beveled tip and/or abullnose tip with a lateral port. The cannula may also be a Touhyneedle, Crawford needle, Hustead needle, Sprotte needle, Whitacreaneedle, Quincke needle, or other medical needles. In a preferredembodiment, the gauge of the needle is in a range from about 6 to about26 and more preferably the gauge of the needle is in a range from about18 to about 20. The cannula may be hollow or solid. The cannula asdescribed with reference to U.S. Patent Application Publication No.2011/0112511, which is hereby incorporated by reference as if fully setforth herein, may be used.

The cannula may also include one or more solid state sensors, e.g.,temperature, pressure, and/or flow rate. Multiple sensors may also beused throughout the lumen of either the cannula and/or catheter. Thesesensors may be configured to communicate wirelessly via Wi-Fi,Bluetooth, and/or other wireless communication protocols as known in theart to a readout or other device (not shown) such as a controller. Ofcourse, the sensors may be hardwired to communicate directly with areadout or other internal or external device.

The terms sheath, sleeve, and catheter are used interchangeablythroughout the specification. The sheath may be constructed as areinforced catheter with various materials. For example, the sheath mayinclude polyesters; polyurethanes; polyamides; polyolefins includingpolyethylene and polypropylene; and any copolymers thereof. Some morespecific examples of suitable materials include, but are not limited to:nylon; polyester elastomer; polyether/block polyamide, such as Pebax,Hytrel, and/or Arnitel; polyamid such as Grilamid; flouro-polymer, suchas Kynar; polyether ether ketone (PEEK); polyethylene (PE);polyurethane; polyolefin copolymer (POC); tetrafluoroethylenes, such aspolytetrafluoro ethylene (PTFE). In a preferred embodiment, the sheathis reinforced with materials configured to substantially prevent kinkingof the sheath.

The catheter may also be constructed, in whole or in part, utilizing avariety of degradable materials, polymeric materials, synthetic ornatural, and combinations thereof. Furthermore, the catheter may becomposed such that the portion of the catheter that enters and remainsin the patient is degradable, but the portion that remains substantiallyoutside of the patient is not degradable. Furthermore, a break point mayexist between the two materials to assist in separating the catheter,e.g., leaving the degradable portion in the body while thenon-degradable is removed. In this type of arrangement the patient wouldnot have to return to the physician to remove the catheter.

Degradable materials include bioabsorable materials, e.g. such as,polymers and copolymers composed from varying amounts of one or more ofthe following monomer examples, glycolide, d,l-lactide, l-lactide,d-lactide, p-dioxanone (1,4-dioxane-2-one), trimethylene carbonate(1,3-dioxane-2-one), ε-caprolactone, γ-butyrolactone, 6-valerolactone,1,4-dioxepan-2-one, and 1,5-dioxepan-2-one.

The sheath may also include solid state sensors, e.g., temperature,pressure, and/or flow rate. The sheath may also include a communicationmeans such as receiver/transceiver for communication via wireless,bluetooth, radio frequency (RF) and/or other protocols as known in theart.

The sheath and cannula may include antibacterial materials such ascoatings and/or micropatterned surfaces to inhibit or prevent unwantedaccumulation of organic and/or inorganic matter of biological origin onsurfaces. The micropatterned surfaces for controlled bioadhesion aredescribed within PCT Application No. PCT/US10/59246, which is herebyincorporated by reference as if fully set forth herein. Themicropatterned surfaces are also sold under the brand name Sharklet™. Inaddition, the coatings may include broad-spectrum antimicrobial coatingssuch as silver, nanosilver and other antimicrobial coatings as known inthe art. In one embodiment, the antibacterial coatings for the catheterand/or cannula are described with reference to U.S. Patent ApplicationPublication No. 2013/0084319, which is hereby incorporated by referenceas if fully set forth herein.

In another embodiment, the invention is directed towards a method foradministering a continuous flow or intermittent bolus of anestheticagent to facilitate a continuous or prolonged nerve block. The methodincludes providing a sheath having a proximal end, a distal end and atleast one lumen extending throughout a portion of the sheath. The sheathmay include an embedded conductive element for transmitting anelectrical signal from a proximal portion of the sheath to a distalportion of the sheath. The method includes providing a cannula into atleast one lumen of the sheath.

The continuous anesthesia nerve conduction apparatus is configured toallow a physician to perform the procedure within approximately tenminutes or less, and preferably within approximately five minutes orless. With a minimal sterile setup, and easy identification of thetargeted nerve(s), positioning the cannula adjacent to the nerve(s)permits the sheath positioning with a single hand in one continuousmotion.

There are several advantages of having a catheter and/or needle that hasa different diameter at a distal region as compared to the body regionor even a proximal region. A few of these advantages are as follows.

During a procedure a vital part of positioning a catheter is to ensurethat the catheter tip is in close proximity to the targeted nerve(s).Identification of the catheter tip is conventionally done by some formof echogenic marking. If the marking is localized only to the tip, thenthe marking is very small and is often difficult to visualize withultrasound imaging. If the marking is along the entire length of thecatheter, then the tip is difficult to distinguish from the cathetershaft. Altering the diameter of the distal portion of the catheter ortip portion from the body portion or shaft of the catheter is a noveland functional way to identify the catheter tip on ultrasound imaging sothe operator can easily determine when the catheter tip is properlypositioned to increase efficacy and reduce the time of the procedure.

By way of example, the space surrounding a neural structure is limitedand the pocket created by hydro-dissection is small. A smaller diameterdistal portion or catheter tip permits the distal portion to moreeffectively attain the shape within the limited space around thenerve(s).

Some nerve blocks are performed in locations where the space between thenerves and the surrounding tissue is very tight. The ThoracicParavertebral block is one such case where the space around the nerve issmall and advancing too far results in puncturing the lung. By having asmaller diameter tip on the catheter and needle, the catheter can bemaneuvered more precisely within the confines of the paravertebralspace.

In a preferred embodiment, a curved needle and/or curved catheter can beutilized with the system. The curved needle helps direct the catheter ina particular direction. Most nerve block procedures are most effectivewhen the catheter is positioned to provide radial spread of localanesthetics. Neural structures are frequently cylindrical in shape andby positioning the catheter to cover an area in a range from about 75degrees to about 280 degrees surrounding a nerve thereby provides thebest radial spread of the local anesthetic. A curved needle allows forthe hydro-dissection at an angle different than that of the insertionangle of the needle and directs the catheter away from a perpendicularorientation to the nerve(s). The curvature of the needle is not so greatas to inhibit the insertion of the needle/catheter unit.

In one embodiment, the medical apparatus includes a catheter having aproximal end, a distal end, a lateral port, a distal end region,proximal end region, and at least one lumen extending from the proximalend to the distal end. The distal end region includes a first diameterand a proximal end region has a second diameter. The apparatus may alsoinclude a disposable pump and cannula configured to be arranged in atleast one lumen. The first diameter may be smaller or greater than thesecond diameter. The first diameter can be configured to taper to thesecond diameter at a transition region or point between the diameters.The taper can be a non-linear taper shape, linear taper shape andcombination of the same.

In one embodiment, the distal end region having a different diameterthan another portion of the catheter can have a total length in a rangefrom about 0.1 cm to about 5 cm, and preferably, the distal end regionhas a total length in a range from about 1 cm to about 1.5 cm. Thediameter of the distal end region may be constant or variable, e.g., itmay include a taper from a proximal end of the distal end region to thedistal end of the catheter. By way of example, the taper can include athird diameter and a fourth diameter. In one embodiment, the fourthdiameter is smaller than the third diameter and the third diameter issmaller than the first diameter. The diameter of the first diameter,second diameter, third diameter, and/or fourth diameter may be in arange from about 5 gauge to 25 gauge, preferably in a range from about17 gauge to about 22 gauge and most preferably in a range from about 18gauge to about 20 gauge.

Any portion of the catheter may include an echogenic material and/orradiopaque material as described herein. The distal end region mayinclude a first material having a first ultrasound visualizationproperty and the proximal end region and/or rest of the catheter mayinclude a second material having a second ultrasound visualizationproperty. In one embodiment, the first material and second material arethe same. In another embodiment, the first material comprises athermoplastic material only and the second material includes athermoplastic material only. In one embodiment, the first thermoplasticmaterial is different than the second thermoplastic material. In apreferred embodiment, the distal end region of the catheter and/orcannula is configured to bend or curve at angle in range from about 5degrees to about 175 degrees relative to the central axis. In oneembodiment, the apparatus may include an electrical connection elementnear a distal portion of the catheter, wherein the electrical connectionelement is configured to be coupled to a nerve stimulator.

The method further includes connecting a syringe configured toadminister a pharmacological agent to the distal end of the cannula andcoupling an electrical signal generator to the embedded conductiveelement or to the cannula directly. Next, the cannula and sheath areinserted simultaneously into the patient. The method includes locatingat least one nerve of the patient with at least one of an electricsignal generated from the electrical signal generator or an activeimaging device and administering a pharmacological agent to the at leastone nerve after advancing and positioning the sheath off of the cannulawith a single hand. If needed, a guidewire is directed through the lumenof the cannula to position the sheath in a semi-circumferential near thenerve(s).

Yet another embodiment of the invention is directed towards a kit, e.g.,a medical package. The kit includes an apparatus for administering acontinuous flow or intermittent bolus of anesthetic agent to facilitatea continuous or prolonged nerve block and directions for use. The kitmay optionally include a pump for administering a pharmacological agent,e.g., a disposable infusion pump. Disposable infusion pumps are known inthe art such as the ON-Q® C-bloc-Continuous Nerve Block System by I-FlowCorporation, PainPump 1, PainPump 2, PainPump 2 BlockAid by StrykerCorporation, and GoPump® or GoBlock® by Symbios. In some embodiments,the kit includes items that have been sterilized and recycled. Theseitems may include for example, portions of the pump and exteriorcomponents such as clips and luers. Several configurations of the pumpmay be used, including pumps described in U.S. Pat. Nos. 5,284,481;7,322,961; 5,352,201 and 5,080,652, each of which is incorporated hereinby reference in their entirety.

Reference will now be made in detail to an embodiment of the presentinvention, example of which is illustrated in the accompanying drawings.

FIG. 1 illustrates an operational systematic view of continuousanesthesia nerve conduction system according to an embodiment of theinvention.

Referring to FIG. 1, the system is generally depicted as referencenumber 100. The system overview 100 includes an exterior portion of asheath 102. The sheath 102 is secured to the skin of the patient withsecuring tab or tabs 103 and anchored to a hub 104. Nerve(s) 106 lyingdeep in tissue below the exterior surface of the patient are targeted toreceive a pharmacological agent. A subcutaneous distal portion of thesheath 108 is shown positioned in close proximity to the targetednerve(s) 106, e.g., nerves of the brachial plexus. The sheath 108 mayinclude a side port and markings to aid with external visualization,e.g., active or passive visualization. The markings may be spaced apartto aid in further visualization and orientation of the side port asshown in FIGS. 28A and 28B.

An infusion pump 110 which may be filled with a pharmacological agent,e.g., pain medication such as a nerve block, is connected to theapparatus via connecting tubing 112, by way of example, with Luerlocking connectors to the hub 104. The pump 110 can include an ON-Q®C-bloc-Continuous Nerve Block System by I-Flow Corporation, PainPump 1,PainPump 2, PainPump 2 BlockAid by Stryker Corporation, and GoPump® orGoBlock® by Symbios. For example, the pump may include a pump asdescribed in U.S. Pat. Nos. 5,284,481; 7,322,961; 5,352,201 and5,080,652, each of which is incorporated herein by reference in theirentirety. Several different configurations of the tubing may be used.For example, a coupler may be used so that the pharmacological agent inthe pump may be directed to multiple locations in the body. In addition,multiple catheter units may be used and different configurations of thecatheter may also be used.

Several different configurations of the pump 110 may be used. In apreferred embodiment, a disposable pump, infusion pump and otherinexpensive pumps as known in the art is used with a continuousanesthesia nerve conduction apparatus. Such as an infusion pump 110 suchas that described in U.S. Pat. No. 5,284,481, which is incorporatedherein by reference, may be used. FIGS. 7 and 8 illustrate exemplaryembodiments of infuser pumps. The infuser pump, designated generally bythe numeral 710, is collapsible and includes an outer collapsible,substantially non-stretchable housing or shell 712, protectively mountedover a combined reservoir and support assembly constructed substantiallylike that set forth in U.S. Pat. Nos. 5,080,652 and 5,105,983, each ofwhich is incorporated herein by reference as though fully set forthherein.

The collapsible housing 712 has a substantially spherical configurationfor confining and guiding the inflatable reservoir or bladder into aconcentric position around the central support member, and enabling itto expand naturally in a spherical configuration as will be described.However, other geometric configurations are also possible for thecollapsible housing. The collapsible housing 712, as seen in FIG. 8, hascoaxial openings defined by tubular sleeve extensions 714 and 716through which the ends of a central support member 718 extends.

An elastic membrane or bladder assembly 720 forming an inflatablereservoir, such as described in the aforementioned patents, is mountedon the cylindrical support member 718. The bladder assembly 720 may be asingle sleeve or multiple sleeves. This is preferably with an innersleeve being a chemically inert sleeve, and the outer sleeve or sleevesbeing highly elastic.

The central cylindrical support member or mandrel 718 includes circulargrooves only one of which, 722 is shown, at the ends thereof into whichportions of the sleeve 720 and housing 712 are biased with a pair ofO-rings, only one of which, 726, is shown. The collapsible housing 712is preferably a non-stretch blow molded housing of five to tenmil-inches in thickness and made of a material such as polyurethane, PVCfilm, and/or polyethylene and is transparent. This forms a simpleinexpensive compact unit with a certain amount of protection for theelastic reservoir.

Certain applications may require a tougher collapsible housing. In suchcases, the housing can be transparent, UV stable, flexible and highlyresistant to puncturing. In this configuration, the housing would beconstructed of a material such as tough composites in a flexible formsuch as a fabric, reinforced thermoplastic, Kevlar material whichincludes a para-aramid synthetic fiber, related to other aramids such asNomex and Technora, and combinations of the same.

The ends of the central support member 718 include reduced diameterextension 730 and 732, with bayonette type couplings for releasablycoupling cup-shaped caps 734 and 736 which extend over and protectivelycover the O-ring connections or clamping of the elastic bladder andcollapsible housing to the support member.

The support member 718 has an inlet or fill port 742 on one end whichcommunicates with a coaxial passage 744, and a transverse passage 746 inwhich is mounted a check valve 748. The cross bore 746 communicates withpassage 744 and inlet port with the interior of the elastic bladder orsleeve 720 and thus the interior of the inflatable reservoir. The checkvalve is also used and is of a generally cylindrical outer shape, with asquare bore extending from one end and closed at the other forming acup-shaped structure. The check valve may be constructed of materialsknown in the art, e.g., an elastomer like silicone, and collapses inwardto allow filling and erects to its normal configuration to prevent backflow. The square bore configuration of the bore insures that it returnsto its normal configuration and does not remain collapsed.

An outlet port through end 732 communicates with a passage 754 thatextends coaxially from the other end of the support member 718, andcommunicates with a cross bore or port 756 with the interior of theelastic bladder or reservoir 720. The port 756 may include a sensor 711to measure flow rate, pressure, liquid volume, and temperature amongother characteristics. Multiple sensors may also be used throughout theinterior. These sensors may be configured to communicate wirelessly viaWi-Fi, Bluetooth, and other wireless communication protocols as known inthe art to a readout or other device (not shown) such as a controller.Of course, the sensors may be hardwired to communicate directly with areadout or other internal or external device.

A tubing set, as shown in FIG. 7 including a tube 752 having a filter758 and a connector 760 at the end, provides a device for connecting anddispensing a fluid to a desired location, such as a catheter (FIG. 1) asdescribed herein. The connector 760 may be permanently attached to thetube 752, or may be removable. Furthermore, any suitable connector maybe used, including a luer connector or others as known in the art.

The collapsible infuser apparatus of FIGS. 7 and 8 is a compact andinexpensive disposable unit. It has a compact configuration, with acollapsed diameter no greater than the outer diameter of the caps 734and 736. For this reason, it is convenient to package in a kit asdescribed herein. Optionally, it may be temporarily housed during use ina protective hard shell housing.

In another embodiment, the pump 110 may be the pump described in U.S.Pat. No. 7,322,961, which is hereby incorporated in its entirety byreference. FIGS. 9 and 10 illustrate an infusion pump or apparatus,generally referred to by the reference numeral 910. The infusionapparatus 910 is operable to deliver a pressurized liquid, such as apharmacological agent, e.g., pain medication, to a desired site such asa catheter (FIG. 1). Preferably, the infusion apparatus 910 isrelatively inexpensive, portable and provides reliable operationthroughout its useful life. The infusion apparatus 910 may be reusableor may be disposable after a single use.

The infusion apparatus 910 desirably includes an infusion pump 912,which is configured to hold a pressurized supply of a fluid, such as apharmacological agent. Preferably, a supply arrangement 914 includes insubstantial part by a length of medical tubing 916, is in fluidcommunication with the infusion pump 912 at a first end. The supplyarrangement 914 supplies the pressurized fluid to the catheter or otherdelivery device, through an appropriate connection device 918 at asecond end. The medical tubing 916 may be formed of any of a variety ofmaterials suitable for use in medical applications. Preferably, suchmaterials are constructed form a polymeric material and substantiallybio and/or chemically inert. Similarly, the connector 918 may be anysuitable device to permit relatively quick and secure connection betweena pair of medical devices, such as a luer lock, for example. Other typesof suitable connectors may also be used.

In a preferred embodiment, the supply arrangement 914 includes a filter920 in serial connection with the medical tubing 916. The filter 920desirably is configured to remove impurities, including air bubbles,from the fluid delivered from the infusion pump 912. The filter 920 maybe any suitable medical filter as known in the art.

Preferably, the supply arrangement 914 also includes a clamp 922, whichis desirably positioned upstream of the filter 920. The clamp 922, in aclosed position, is configured to apply a squeezing pressure to themedical tube 916 to close the lumen therein and occlude fluid flowbeyond the clamp 922. Any suitable type of medical clamp may be used.

With reference to FIG. 10, the infusion pump 912 generally includes anelastic sleeve 924 surrounding a support member. Preferably, the supportmember 926 is generally cylindrical in shape; however, other suitableshapes of support members may also be used. The elastic sleeve 924 isexpandable in a radial direction about the cylindrical support member toan expanded condition 924 a. In the expanded condition 924 a, theelastic sleeve 924 and the support member cooperate to define a variablevolume fluid reservoir 928 therebetween.

Preferably, the infusion pump 912 is configured such that the reservoir928 may be filled (also referred to as “loading” the pump 912), from aninlet end 926 a of the support member. Preferably the infusion pump 912may be manually loaded with a loading device, such as a syringe. Oncethe reservoir 928 has been filled with fluid, the elastic nature of thesleeve 924 exerts a pressure on the fluid within the reservoir 928,permitting the fluid to be delivered to a desired site catheter throughthe supply arrangement 914 and delivery device, e.g., device of FIG. 1.

The sleeve 924 may include a single layer or multiple layers. The innersleeve 924 a may include a bio and/or a chemically inert material toavoid interaction with the drug within the infusion pump 912 while anouter sleeve 924 b may include a material having desirable elasticproperties. The combination of the sleeves 924 a, 924 b desirablyprovide satisfactory elastic properties and desirable chemicalproperties to consistently and safely deliver the pressurized fluid,such as a pain medication. In one arrangement, the inner sleeve 924 amay include a semi-elastic thermal plastic material. The outer sleeve924 b may include a natural latex rubber material, which providesdesirable elastic characteristics. However, other suitable materials mayalso be used.

If desired, the infusion pump 912 may also include a protective,collapsible housing, or pouch 930 surrounding the elastic sleeve 924.Desirably, the pouch 930 is relatively inelastic to limit expansion ofthe sleeve 924. In addition, the pouch 930 desirably is made from atougher material than that of the sleeve 924 in order to protect thesleeve from punctures, or other damage. In one preferred arrangement,the pouch 930 includes a pair of flat, sheet-like portions bonded to oneanother around their peripheral edges. Preferably, the portions of thepouch 930 comprise a PVC material, which are bonded to one another byRadio Frequency (RF) welding. Such a construction provides a suitable,economical means to protect the elastic sleeve 924 from damage. Othersuitable materials and construction techniques may also be employed.

Desirably, the elastic sleeve 924 is sealed to the cylindrical supportmember 926 at spaced apart locations near each end 926 a, 926 b of thecylindrical support 926 by a pair of seal assemblies 932 (only oneshown). The reservoir 928 of the infusion pump 912 is defined betweenthe pair of seal assemblies 932. If a housing or pouch 930 is provided,end portions thereof may also be held in place by the seal arrangement932. These and other details of the sealing arrangements 932 aredescribed in greater detail below.

Desirably, a cap 934 is attached to each end of the infusion pump 912.Preferably, each cap 934 includes a side wall portion which at leastpartially covers the sealing arrangement 932. Such an arrangement servesto inhibit damage to the sealing arrangement 932 during normal use ofthe infusion apparatus 910 and provides an aesthetically pleasingoutward appearance. Other sealing mechanisms may be used.

The cap 934 is removably connectable to the support member 926. In apreferred embodiment, the cap 934 is coupled to the support member 926by a snap fit arrangement wherein the cap 934 includes atriangular-shaped cutout 936. The cutout 936 is sized such that aportion of each side of the triangular-shaped cutout 936 may be receivedwithin an annular recess defined by the cylindrical support member 926.Desirably, the cap 934 is constructed from a material having sufficientflexibility such that the side portions of the cutout 936 may deflect topass over the end portion of the support member 926, which has a largerdiameter and is positioned outwardly, along the support member 926, fromthe recess. Any of a variety of common thermoplastic materials may besuitable for use in construction of the end cap 934. Other suitable endcap constructions may be used, such as a threaded end cap arrangement,plug, and the like.

The infusion pump 912 also includes an inlet 940 and an outlet 942 influid communication with the reservoir 928. In the illustratedembodiment, the inlet 940 and outlet 942 are at least partially definedby the support member 926. Desirably, each of the inlet and outlet 940,942 include a longitudinally extending channel 944, 946, respectively,which open to opposing end surfaces of the support member 926. Inaddition, each of the inlet and outlet 940, 942 include a radiallyextending channel 948, 950, respectively, which communicate with thelongitudinal channels 944, 946 and open from a portion of the side wallof the cylindrical member 926 located within the fluid reservoir 928, orthe reservoir wall. A sensor 911 to measure flow rate, pressure, liquidvolume, and temperature among other characteristics. Multiple sensorsmay also be used throughout the interior of the infusion pump 912. Thesesensors may be configured to communicate wirelessly via Wi-Fi,Bluetooth, and other wireless communication protocols as known in theart to a readout or other device (not shown) such as a controller. Ofcourse, the sensors may be hardwired to communicate directly with areadout or other internal or external device.

The inlet-defining end 926 a of the support member 926 desirably isconfigured to receive a reservoir loading device, such as a syringe,which may be interconnected to the support member 926 by a threadedconnection, such as a luer lock connection, for example. In operation,the loading device introduces fluid into the fluid reservoir 928,against the biasing force of the sleeve 924. Desirably, once theinfusion pump 912 has been loaded with fluid, the inlet end of thesupport member 926 is closed by a cap 952. The elasticity of the sleeve924, once expanded 924 a, pressurizes the fluid within the reservoir928.

Preferably, the inlet 940 includes a one-way valve to inhibit fluidwithin the reservoir 928 from escaping through the inlet 940. The valveincludes a valve member 954 positioned within the radially extendingchannel 948. The valve member 954 is desirably cylindrical in shape andincludes a recess extending, from an end surface, along a longitudinalaxis of the valve member 954. Preferably, the recess is generally squarein cross-section and extends substantially the entire length of thevalve member 954, thereby defining a closed end of the valve member 954having a thickness approximately equal to a thickness of the outer wallportion of the valve member 954.

When installed in the radially extending channel 948, a portion of thewall of the valve member 954 facing the longitudinal channel 944collapses in response to fluid being loaded in the infusion pump 912through the inlet 940. However, once the fluid pressure within the inlet940 is lower than the pressure within the reservoir 928 (i.e., fillingof the reservoir 928 has ceased), fluid within the recess urges thevalve member 954 back into its original, cylindrical orientation toinhibit fluid from entering the longitudinal channel 944 and, thus,exiting the reservoir 928 through the inlet 940. Other suitable valvesmay also be used as known in the art.

Desirably, the longitudinal channel 946 of the outlet 942 extendsthrough an outlet end 926 b of the support member 926 and communicateswith the medical tubing 916 of the supply arrangement 914. Desirably,the outlet 942 permits relatively unobstructed fluid flow. That is, aone-way valve mechanism is not necessary or desirable in connection withthe outlet 942. Accordingly, with such an arrangement, fluid flow fromthe reservoir 928 through the outlet 942 is selectively permitted by theclamp 922 of the supply arrangement 914.

Optionally, the pump 912 may include a flow restrictor (not shown)downstream from the fluid reservoir 928. The flow restrictor isconfigured to restrict the flow rate of fluid exiting the fluidreservoir 928 to a desired level. The flow restrictor may comprise areduced-diameter of the outlet passage 946 (in whole or in part), thediameter of the tubing 916 (FIG. 9), or a separate flow restrictordevice positioned downstream from the fluid reservoir 928. Othersuitable arrangements are also possible, including a combination of theabove-mentioned flow restrictor arrangements.

The seal arrangement 932 is described in greater detail. The sealarrangement 932 desirably includes an annular recess, or groove 958,near an end of the support member 926. The recess 958 is defined by anouter surface of the support member 926 and, preferably, issubstantially semi-circular in shape. A generally annular spring clip960 is sized to be positionable onto the support member 926 and,preferably, cooperate with the recess 958 to create a seal between thesleeve 924 and the support member 926.

The spring clip 960 is configured to be movable from a relaxed position,or a free diameter of the spring clip 960, to a deflected position. Inthe relaxed position, an inner diameter of the spring clip 960 desirablyis smaller than a diameter of the support member 926 with which thespring clip 960 is positioned. In the deflected position, the innerdiameter of the spring clip 960, desirably, is large enough to pass overthe elastic sleeve 924 and cylindrical support member 926 to permitassembly onto the infusion pump 912. Once released, the spring clip 960returns toward the relaxed position. Preferably, the support member 926is sized such that the spring clip 960 is prevented from returning tothe fully relaxed position. Accordingly, the spring clip 960 exerts asqueezing force on the elastic sleeve 924 to create a seal between thesleeve 924 and the cylindrical support member 926 thereby defining anend of the fluid reservoir 928. As will be appreciated by one of skillin the art, the squeezing force developed by the spring clip 960 may beadjusted to a desired level by altering the relative sizes of the innerdiameter of the spring clip 960 and the outer diameter of thecorresponding portion of the support member 926, as well as by alteringthe properties of the spring clip 960 itself, such as the coil diameterof the spring clip 960, for example.

Desirably, the elastic sleeve 924 (and pouch 930, if provided) is biasedinto the recess 958 by the spring clip 960. Such an arrangement assistsin defining and maintaining a proper position of the spring clip 960relative to the support member 926. In addition, the deflection of thesleeve 924 into the recess 958 increases the effectiveness of the sealarrangement. Although only the inlet side 926 a seal arrangement 932 isshown, preferably the outlet side 926 b is constructed substantiallysimilarly to that of the inlet side 926 a. Preferably, the spring clip960 is constructed of metal; however, other suitable materials such asplastics may also be used.

In another embodiment, the system may include a pump 110 as described inU.S. Pat. No. 5,352,201, which is incorporated in its entirety byreference. FIGS. 11 and 12 illustrate the infusion pump or apparatus,generally referred to by the reference numeral 1010. The infusionapparatus is embodied in a housing having a generally flat spiralconfiguration. However, it may have other outer configurations such ascircular, semicircular or square. The apparatus includes a main housinghaving thermally formed walls extending upward from a bottom andextending in a radially outward spiral to a terminal end such that allthe connections are provided. The main housing has an open top formedfor receiving a generally flat planer cover 1014. The cover 1014 may beformed with recesses or other structural configurations to enablestacking of a plurality of the units.

The housing is preferably formed of any one of a number ofthermoformable plastic polymer materials and vacuum formed into itsshape or configuration. Either the housing 1012 or the cover 1014 orboth may be of a transparent material. Preferably at least one istransparent in order to enable viewing the components in the interior ofthe housing. They may also be formed together of the same material withan integral hinge connection as will be explained. Referring to FIG. 12,the main housing is shaped to form a spiral bladder support and chamberfrom a central point of the housing spiraling outward to the terminaloutlet face of the housing. The housing is formed of an inner wall 1016beginning at an inner end 1018 proximate the center of the housing andspiraling outward in a radially outwardly spiral to become an outer walland continue to a terminal end 1022, joining the outer surface orportion thereof and forming a terminal wall 1024. The angle subtended bythe spiral is preferably in a range from about ¾ turn and about twoturns or greater.

The inner wall 1016 forms a spiral support structure for supporting anelongated elastic tubular member 1026 forming an elastic bladder orreservoir. The coils of the elastic tube are supported in a common planeand spiral radially outward. The elastic tube or member 1026 ispreferably pre-stretched up to about 30% with an inner end 1028 securedon a barbed plug 1030 having a shoulder 1032. The shoulder 1032 ispositioned behind shoulders formed by inner extending wall portions 1034and 1036 forming a receptacle for receipt of the plug 1030. The elastictube or member is stretched and bends across the inner end 1018 or wallof mounting member 1016 and lies compressed substantially flat, as itextends along the wall to an outlet end 1038 connected to an outletconnector and valve assembly including a suitable coupling or connectorsuch as a luer connector 1040.

The housing of the valve and connector assembly is of a tubularconfiguration with an inner barbed connector 1042 over which an outerend 1038 of elastic tube 1026 is mounted. The housing of the connectorincludes spaced apart disc or shoulder plates 1044 and 1046 whichembrace and engage opposing sides of the wall 1024 as the connector isinserted in a slot 1048 therein. This secures the connector in placeagainst movement either inward or outward of the housing. The elasticbladder 1026 is stretched and mounted between barbed connectors 1030 and1042.

The connector assembly 1040 preferably includes a luer check valve of atype for such fittings normally available from the Halkey-RobertsCompany of St. Petersburg, Fla. The valve (not shown) is a one-way checkvalve to prevent outflow until a luer connector is mounted on the outletend of the connector which acts to release or unseat the valve.

The housing may be constructed of any number of suitable engineeringthermo forming materials such as, acrylonitrile butadiene-styrene (ABS),polyvinylchloride (PVC), polyethylene terephthalate (PET), polyethyleneterephthalate glycol (PETG) and the like. These are well-knownlightweight plastics and are materials approved for medical devices.

The tubular member 1026 is preferably constructed of an inner tube orsleeve of an inert elastomer and an outer highly elastic tube or sleeve.A preferred rubber material for the inner sleeve is a thermoplasticmaterial, e.g., rubber sold under the mark KRATON by Shell ChemicalCompany of Houston, Tex. These materials are available as KRATON D and G2000 series rubber. These materials are biocompatable and have less thanoptimum elastic characteristics, and are referred to herein assemi-elastic. When stretched, they initially return to a position ofabout 75 to about 90 percent of original configuration over a reasonableperiod of time.

The outer sleeve is preferably made of a natural or synthetic highlyelastic rubber such as latex, silicone or other rubber with excellentelastic characteristics, and is referred to herein as elastic. Amaterial with good elastic characteristics returns quickly from astretched condition to its original un-stressed or un-stretchedcondition. A good elastic material also has a uniform elastic force overthe range stretched and returns energy put into it. A good elasticrubber can stretch in the range from about five hundred to about eighthundred percent and return most of the energy as it returns to itsoriginal position. Natural latex rubbers are a preferred material forthe outer sleeve of tubular member 1026. However, certain other rubberssuch as silicone rubber would also be suitable.

The pump 1010 may include a sensor to measure flow rate, pressure,liquid volume, and temperature among other characteristics. Multiplesensors may also be used throughout the interior. These sensors may beconfigured to communicate wirelessly via Wi-Fi, Bluetooth, and otherwireless communication protocols as known in the art to a readout orother device (not shown) such as a controller. Of course, the sensorsmay be hardwired to communicate directly with a readout or otherinternal or external device.

Still another embodiment of system includes a pump 110 as described inU.S. Pat. No. 5,080,652, which is incorporated by reference in itsentirety. FIGS. 13 and 14 are directed toward a pump generally depictedas reference number 1310. The pump 1310 is separate from the charging orfiller pump. Moreover, it may be filled by any suitable means, such as asyringe or any other pressurizing devices or methods. The housing 1312has a substantially spherical configuration and is provided withcoaxial, or more particularly aligned bores or ports 1314 and 1316, inwhich is mounted an inflatable bladder assembly. The housing 1312 may bemade of unitary construction, such as by blow molding, or may be of twoidentical half shells assembled. The ports are formed in axial recesses1318 and 1320. The inflatable bladder assembly includes a first or innerelongated semi-elastic sleeve 1322, and a pair of outer elongated latexrubber elastic sleeves 1324 and 1326 mounted on an elongated centralcylindrical support member 1328. The inner sleeve 1322 is preferablymade of a drug compatibility rubber with low leach characteristics thatmeets USP class 6 testing standards.

A rubber material for the inner sleeve 1322 is a class of thermoplasticrubber, e.g., sold under the mark KRATON by Shell Chemical Company ofHouston, Tex. These materials are available as KRATON D and G 2000series rubber, and have FDA status for use in certain applications oringredients of articles for food contact. These materials have less thanoptimum elastic characteristics, and are referred to herein assemi-elastic. When stretched, they return to a position of about 75 toabout 90 percent of original configuration.

The outer sleeves 1324 and 1326 are preferably made of a natural latexrubber with excellent elastic characteristics. A material with goodelastic characteristics returns from a stretched condition to itsoriginal un-stressed or stretched condition. A good elastic materialalso has a uniform elastic force over the range stretched. Natural latexrubbers are the preferred material for the outer sleeves membranes 1324and 1326.

The central support member 1328 is preferably of a generally elongatedcylindrical configuration, with an annular radially extending retainingflange 1330 on one end for engaging a shoulder 1332 on the housing 1312.The opposite end of the support member 1328 includes a bayonet typecoupling with a retaining nut 1334. The central support member may beconstructed of any suitable pharmaceutically compatible material, suchas metals, plastics, glass, etc.

The support member 1328 includes an inlet port 1352 communicating by wayof a passage 1354, including a one-way valve 1356, 1358 with theinterior of the membrane or sleeve 1322. Any suitable check valve may beused to permit uncoupling of the filling unit without leakage of fluidfrom the pressurized bladder. The check valve includes a cross throughbore 1356 communicating with the end of passage 1354, and in which isslip fitted an elastic tube 1358, which may be of a suitable rubber suchas silicone. The tube 1358 covers the end of passage 1354 to preventback flow from inside the bladder formed by sleeve 1322. The tube 1358collapses in response to higher pressure in passage 1354 enabling flowof liquid into sleeve 1322.

A sensor 1311 before the valve is configured to measure flow rate,pressure, liquid volume, and temperature among other characteristics.Multiple sensors may also be used throughout the interior. These sensorsmay be configured to communicate wirelessly via Wi-Fi, Bluetooth, andother wireless communication protocols as known in the art to a readoutor other device (not shown) such as a controller. Of course, the sensorsmay be hardwired to communicate directly with a readout or otherinternal or external device. The sensors may be configured tocommunicate with the flow control device 1370, e.g., a feed-back loop asknown in the art.

An outlet passage 1360 in support member 1328 communicates via an outletport 1362 and suitable coupling assembly 1364, with an outlet orintravenous feeding line including, e.g., a two-part tube 1366, whichincludes a filter 1368, and may include flow control device 1370 and amale luer lock adaptor. The outlet line may be controlled by a suitablevalve assembly (not shown) or preferably by the well known type clampknown as a clamp 1396. The luer lock 1374 has a valve that closes theoutlet port when the feeding line is uncoupled therefrom. The couplingis effective to open the outlet valve when coupled to the outletfitting. The delivery tubes 1366 may be selected in size and length toaid in maintaining a predetermined pressure and flow rate. The luer lockis configured to attach to a catheter, e.g., as shown in FIG. 1.

The elastic sleeves 1324 and 1326 are mounted over the sleeve 1322.Sleeves 1324 and/or 1326 may be stretched radially when in position oversleeve 1322, e.g. 1324 is stretched radially over 1322, with 1326 slipfit over the assemblies of 1322 and 1324. The outer bladder 1326 slipsradially over the assembly of 1322 and 1324. The composite assembly of1322, 1324, 1326 is slideably engaged with a slip fit over the mandrelor support member 1328. Radial stretching of the bladder 1324compensates for material 1322's less than perfect elasticity. Morespecifically, the wall thickness and amount of stretch of bladder 1324are selected to just compensate for bladder 1322's material less thanperfect elasticity. The initial strain conditions and bladder wallthicknesses are also chosen to minimize the non-linearity exhibited in abladder's stress versus strain.

It is well known that a single bladder infusion device constrained atboth ends exhibits a highly non-linear stress versus strainrelationship. This causes a time varying flow characteristic. The innerbladder is chemically inert and the outer bladder is elastic. Thestructure and method for maintaining constant flow versus time while thedevice is infusing by radially stretching an intermediate bladder overthe inner bladder.

The inner semi-elastic drug compatible tube or membrane 1322 is mountedon the cylindrical support member 1328, preferably in a slightly snugbut un-stretched radial fit, and essentially relaxed elongated ornon-stretched longitudinal fit. The inner sleeve 1322 preferably haswhat shall be called a slip fit on the support member. This slip fit ispreferably with a clearance on the order of about one-thousandths of aninch of the sleeve on the support. This provides a non-stretched fit,with essentially zero volume of the pressure chamber when in thenon-stretched or totally relaxed state or mode.

The elastic sleeves 1324 and 1326 are respectively stretch fit and snugfit radially over the inner semi-elastic sleeve 1322. The intermediatesleeve 1324 is radially stretched up to about five percent over theinner sleeve 1322 for compressing it. The outer sleeve 1326 is slipfitted over the intermediate sleeve 1324. All of these sleeves 1322,1324, and 1326 are fitted over the support member 1328 and clamped atthe ends with a pair of O-rings 1376 and 1378. These O-rings 1376 and1378 bias the ends of the multiple sleeves into annular grooves 1380 and1382 in the outer surface of the member 1328. The O-rings 1376 and 1378are held in place by the walls of the housing forming the recesses 1318and 1320. The multiple sleeves when being filled tend to elongate androll over the ends thereof as shown in FIG. 14. The support member 1328is of a fixed length and holds the ends of the sleeves at a fixedposition. The multiple thin sleeves easily roll over the ends, thereofas the bladder is made up of the multiple sleeves it fills and expands.

The pressure applied by the pressure chamber, formed by the multiplesleeves, will be substantially a function of the thickness of the wallof the elastic sleeve or sleeves. For example, a typical two to three(2-3) psi may be obtained by a wall thickness of about eighteen totwenty-thousandths (0.018-0.020) of an inch. In order to obtain higherpressure with superior uniformity, a multi-layered sleeve configurationas described hereinabove has been found to be preferred.

As illustrated in FIG. 13, a plurality of sleeves (three illustrated)1322, 1326 and 1324 are slip fitted (non-stretched) on the supportmember. The inner sleeve 1322 is slip fitted on the support member 1328,and a second sleeve 1324 is slightly stretch fitted over the firstsleeve 1322. Thereafter, a third sleeve 1326 is slip fitted over theintermediate sleeve 1324. These are shown in the fully deflated positionin FIG. 13 and in the fully inflated condition in FIG. 14, showing thefold or roll over the ends. These multiple layers have been found to besuperior to the use of thicker membranes or sleeves to obtain higher anduniform pressures. The use of multiple layers also enables the use of asemi-elastic substantially chemically (medically) inert inner membraneor sleeve for contact with the infusible liquid. The multiple sleeveswill roll or fold over at the ends, as illustrated in FIG. 14. Thus, toincrease the pressure, additional sleeves of substantially the samethickness are used.

When being filled, the elastic multi sleeve membrane has a tendency toelongate, but expands into a spherical configuration. The elongation isaccommodated in this pump configuration by an accordion effect at theends of the bladder, as shown in FIG. 14, wherein the bladder rolls overthe ends thereof and outward along the support member 1328 as it expandsoutward to fill the housing 1312. The accommodation of the elasticmembrane in the spherical configuration enables it to expand andcontract in its natural fashion, and to maintain a substantiallyconstant pressure and thereby flow rate over the intravenous injectionperiod.

The layered or multiple sleeve configurations have been found to betteraccommodate the accordion fold and maintain a more uniform pressure thana thicker sleeve. The tubular elastic sleeve membranes are selected andmounted on the support member in a manner that enables them to roll orfold over at the ends when being filled.

In operation, an assembled infuser pump unit is selected, and the inletport 1352 is secured to a source of fluid under pressure. As fluid isbeing introduced into the inlet, the valve 1358 collapses as fluid flowsinto the inner sleeve or membrane 1322. As the reservoir or bladderformed by the sleeves begins to fill, it expands and attempts toelongate. The ends of the sleeves begin to fold and roll over the endsthereof as in FIG. 14. The bladder forms a substantially spherical shapeas its natural form of expansion. The roll at the ends accommodates thisexpansion and aids in maintaining a substantially constant pressure overthe range of infusion.

As the bladder deflates, the outer elastic membranes force the innersemi-elastic membrane back to substantially its original position. Thishelps to evacuate the entire volume of fluid. It also will beappreciated that any form of pressurized filling apparatus may be used.

FIG. 2A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 2B illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus shown in FIG. 2A.

Referring to FIGS. 2A-2B, a continuous anesthesia nerve conductionapparatus is generally depicted with reference to number 200. Theapparatus 200 includes a reinforced catheter 202 with and without thecannula 204. The beveled distal tip of the cannula 204 is shown to beprotruding slightly from the distal tip of the catheter 202. The tip mayalso be curved. The proximal portion of the catheter 202 includes wingedhub 206. The cannula 204 includes a hub 207 configured to abut andengage with the winged hub 206 via a locking mechanism 208. The wings210, 212 optionally include an adhesive configured to attach to apatient. Optionally, the wings may also include a warning labelconfigured to indicate and distinguish the type of catheter, e.g.,anesthesia catheter versus an intravenous (IV) catheter. The catheter202 optionally includes at least one port 214. The port 214 isconfigured to supply a pharmacological agent in at least a radialdirection from a longitudinal axis of the catheter 202. That is, theport 214 permits the distribution of the infused pharmacological agentto the targeted nerve(s) 116 in a circumferential and linear pattern atthe distal end. The port 214 may be configured to have small or largediameters, e.g., a diameter in the range from about 0.1 mm to about 2 mmor greater. There also may be a plurality of ports arrangedcircumferentially around the perimeter of the catheter, linearly done inaxis of the catheter, and/or in another predetermined geometric pattern.

The proximal hub 207 of the cannula 204 is configured to accept a tip ofa standard syringe 218. The hub 207 may include alignment marks asdescribed herein, e.g., with reference to FIGS. 31A-33. The syringe 218may be used to inject a pharmacologic agent, e.g., solution forhydro-dissection of tissue surrounding to the targeted nerve(s) 106during catheter placement. Once in place adjacent to the targetednerve(s) 106, the lock 208 is disengaged, the cannula 204 is withdrawn,and the catheter 202 is positioned to provide continuous nerve block.

The catheter hub 206 is further configured to accept a connector 219 onthe end of the connecting tube 112. The connecting tube 112 is coupledto an infusion pump on the opposite end. A frictional region 220, e.g.,pebbled region, is optionally added to a proximal portion of thecatheter 202. The frictional region 220 is configured to aid in sealingan insertion site in the tissue, minimize leakage of contrast and/orpharmacological agent, and minimize movement of the catheter 202. Thefrictional region 220 may include an adhesive material including abioresorable material and non-bioresorable material. Alternatively,instead of or in combination with the friction material 220 the proximalportion may have an enlarged diameter to further aid in sealing theinsertion site. The enlarged diameter may be greater than the diameterof the rest such that the diameter is about 2% to about 15% greater thanthe diameter of the rest of the catheter. The orientation and thelocation of the catheter 202 and its lateral port can be monitoredthrough the use of markers, e.g., radiopaque, echogenic, combinations ofthe same, and the like, via visualization techniques.

Referring now to FIG. 2B, the distal portion of the catheter 202includes an echogenic region 222 including echogenic material to aidwith ultrasound visualization of a distal tip of the catheter 202. Thecatheter 202 includes a lumen 226 extending from a proximal end to adistal end. The hub 206 also includes a lumen 228 in communication withthe lumen 226. Finally, the cannula 204 and hub 207 of the cannulaincludes a lumen 230 extending from a proximal end to a distal end. Thelumens 226, 228, and 230 are arranged to form one continuous lumen foradministering a pharmacological agent or other medical device. The othermedical device may include a balloon, active visualization device(imaging probe), surgical instrument, and the like. A reinforcementmaterial 224, e.g., axial stays, metal and the other reinforcementmaterial may be used for reinforcement of the catheter to minimizekinking or bending when desired. That is, the material 224 is embeddedin a body of the catheter 202 to provide enhanced rigidity, therebypreventing bunching and kinking of the catheter 202. The catheter 202may also be configured with various rigidities along a longitudinal axisof the catheter, e.g., the proximal portion may be stiffer than thedistal portion and vice versa. Optionally, an anti-restrictive member orsupplemental catheter may be used to further prevent kinking asdescribed herein, e.g., with reference to FIGS. 37A-37G.

FIG. 3A illustrates a perspective view of the continuous anesthesianerve conduction apparatus according to another embodiment of theinvention. FIG. 3B illustrates a cross-section view of the continuousanesthesia nerve conduction apparatus shown in FIG. 3A. FIG. 3Cillustrates an enlarged view of the distal section of the apparatusshown in FIG. 3A.

Referring to FIGS. 3A-3C, a continuous anesthesia nerve conductionapparatus is generally depicted with reference to number 300. Theapparatus 300 includes a reinforced catheter 302 with and without acannula 304. The beveled distal tip of the cannula 304 is shown to beprotruding slightly from the distal tip of the catheter 302. Theproximal portion of the catheter 302 includes a winged hub 306. Wings308, 310 optionally include an adhesive configured to attach to apatient. The catheter 302 optionally includes at least one port 312. Theport 312 is configured to supply a pharmacological agent, e.g.,contrast, medicine, or the like, in at least a radial direction from alongitudinal axis of the catheter 302. That is, the ports 312 permit thedistribution of the infused pharmacological agent to the targetednerve(s) 116 in a circumferential and/or linear pattern.

The apparatus 300 further includes an embedded conductive element 314and a conductive 316 tab. The conductive element 314 is configured totransmit electrical activity used to activate a nerve, e.g., dc current,voltage, ac current, square wave, or combination, to a distal portion ofthe catheter 302 and cannula 304. In a preferred embodiment, theelectrical activity is generated by a nerve stimulator generator (notshown), e.g., Stimuplex® HNS11 Peripheral Nerve Stimulator by B. Braun,Stimuplex Dig RC by B. Braun, MultiStim VARIO by Pajunk, and EzStim®stimulator by Life-Tech International. In a preferred embodiment, theembedded conductive element 314 is an embedded wire.

An electrode cap 318 is affixed to a distal end of the catheter 302. Theelectrode cap 318 is coupled to the embedded wire 314 and is configuredto allow for peripheral nerve(s) simultaneous stimulation via thecannula 304 and the catheter 302. The embedded wire 314 is within thebody of the catheter and connects the electrode cap to the proximalelectrode connector 316 on the catheter hub 306.

In this embodiment, an electrical signal is to be introduced via aperipheral nerve stimulator connected to the proximal electrodeconnector 316 and propagated to the electrode cap 318 on the distal tipof the catheter 302 with an internal conductive wire 314. The electrodecap 318 provides transmission to a distal tip of a cannula 304. Thecatheter body 302 acts as an insulator for the rest of the cannula 304.Therefore, transmission of a signal with a single connection may besupplied via a distal tip of the cannula 304, the electrode cap 318 orsingly via the electrode cap 318 by retracting the cannula 304 proximalof the electrode cap 318. Optionally, the outer surface of the electrodecap 318 may be insulated with an insulated material. In this embodiment,when an electrical signal is applied to the outer surface of theelectrode cap 318 does not transmit an electrical signal as it isinsulated.

A proximal hub 320 of the cannula 304 is further configured to accept atip of a standard syringe (not shown). The proximal hub 320 includes aconnector 322 for releasably coupling cannula hub 320 to the catheterhub 306. The catheter hub 306 is further configured to accept aconnector (not shown) on an end of the connecting tube 112. Theconnecting tube 112 is coupled to an infusion pump on the opposite end(FIG. 1, 110). A frictional region 324, e.g., at least a partiallycoarse region, is optionally added to a proximal portion of the catheter302. The frictional region 324 is configured to aid in sealing aninsertion site in the tissue, minimize leakage of contrast and/orpharmacological agent, and minimize movement of the catheter 302.Moreover, the diameter at the frictional region may also be enlarged asdescribed herein.

A distal portion of the catheter 302 includes an echogenic region 323including echogenic material to aid with ultrasound visualization of adistal tip of the catheter 302. The echogenic material may includemetallic flakes, reflective flakes derived from titanium, stainlesssteel, copper or other similarly inert metals or alloys that reflect thesound waves generated by the ultrasound probe. The catheter 302 includesa lumen 326 extending from a proximal end to a distal end. The hub 306also includes a lumen 328 in communication with the lumen 326. Finally,the cannula hub 320 includes a lumen 330 extending from a proximal endto a distal end. The lumens 326, 328, and 330 are arranged to form onecontinuous lumen for administering a pharmacological agent or othermedical device. The other medical device may include a balloon, activevisualization device (imaging probe), surgical instrument, and the like.

A reinforcement material 332, e.g., axial stays, metal and the like asknown in the art, is added to a body of the catheter 302 to provideenhanced rigidity, thereby preventing bunching and kinking of thecatheter 302. A plurality of reinforcement material 332 may be used. Thecatheter 302 may be configured with various rigidities along alongitudinal axis of the catheter, e.g., the proximal portion may bestiffer than the distal portion.

FIG. 4 illustrates an enlarged view of a distal section of theconduction apparatus according to yet another embodiment of theinvention.

Referring to FIG. 4, a distal tip of the apparatus is generally referredto as reference number 400. The rest of the apparatus (not shown) issimilar to the catheter described in FIGS. 3A-3C and will not bedescribed further. In this embodiment, the distal tip of the catheter302 includes a retractable flap 402. The distal port of the catheter ispatent while the introducing cannula 304 is inserted through the lumenof the catheter 302, but the retractable flap 402 is configured todeploy once the cannula 302 is withdrawn; that is, retractable flap 402is configured to move from a closed position to an open position asshown. In a closed position and when the catheter is in use, only theside port 312 is utilized to deliver pharmacological agent.

FIG. 5 illustrates an enlarged view of a distal section of theconduction apparatus according to yet another embodiment of theinvention.

Referring to FIG. 5, a distal tip of the apparatus is generally referredto as reference number 500. The rest of the apparatus (not shown) issimilar to the catheter described in FIGS. 3A-3C and will not bedescribed further. In this embodiment, the distal tip of the catheter302 includes a plurality of retractable flaps 502 that are configured inan open position and closed position by movement of a cannula 304. Morespecifically, the distal port of the catheter is patent while theintroducing cannula 304 is inserted through the lumen of the catheter302, but the retractable flap 502 is configured to deploy once thecannula 304 is withdrawn; that is, retractable flap 502 is configured tomove from an open position to a closed position. In a closed positionand when the catheter is in use, only the side port 312 is utilized todeliver pharmacological agent.

FIG. 6A illustrates a perspective view of the continuous anesthesianerve conduction apparatus according to another embodiment of theinvention. FIG. 6B illustrates an enlarged view of a distal section ofthe continuous anesthesia nerve conduction apparatus according of FIG.6A in various configurations.

Referring to FIGS. 6A-6B, a continuous anesthesia nerve conductionapparatus is generally depicted with reference to number 600. Theapparatus 600 is similar to the apparatus described with reference toFIG. 3A-3C except for the distal portion of the reinforced catheter 602.The distal portion of the reinforced catheter 602 with a preformedshape, controllable shape or resilient shape. In one embodiment, when acannula 604 is inserted through the lumen of the reinforced catheter602, the distal tip of the catheter is straightened by the cannula 604,but when the cannula 604 is withdrawn, the distal tip takes itspreformed shape. The shape may be an “L” shape as noted with referenceto element 606, “U” shape as noted with reference to element 608, orcurved as in 610. The proximal electrode connector 612 is positioned onthe side of the proximal catheter hub 614 so that the direction of thepreformed distal tip of the catheter is corresponding with the electrodeconnector 612. Alternatively, the distal end portion of the catheter 602may be controllable with a wire system (not shown) to variousgeometries, e.g., “L” shape, “U” shape, or curved shape. The variousgeometries allow the distal portion of the catheter to be closer to adesired nerve or nerve bundle thus permitting a better distribution onanesthetic solution while keeping more of the catheter in closeproximity to the nerve(s).

Catheters as described herein may be constructed, in whole or in part,utilizing a variety of degradable materials, polymeric materials,synthetic or natural, and combinations thereof. Furthermore, thecatheters may be composed such that the portion of the catheter thatenters and remains in the patient is degradable, but the portion thatremains substantially outside of the patient is not degradable.Furthermore, a break point may exist between the two materials. Thebreak point may be configured to facilitate breaking.

In some embodiments, the catheters may be composed of multiplecomponents that are mixed as a blend, such as a plasticized system,and/or as a microphase immiscible system. If suitable reactive groupsare introduced into the formed catheters, what is commonly known as athermoset, or chemically cross-linked system can be generated underappropriate curing conditions. The formed catheters can also be composedin the form of a laminate or a fibrous reinforced composite. Of course,the properties of the selected composition, e.g., molecular weight,glass transition temperature(s), crystallinity, and/or the extent ofcross-linking will dictate the desired properties of the catheters. Thecatheters may also be coated with a variety of therapeutic agents suchas pain, antibacterial, antimicrobial or anti-inflammatory coatings,drug coatings, and the like. The catheters may also be composed ofand/or coated with anti-microbial materials and micro surfaces such assilver nanoparticles, for example the catheter may be impregnated withsilver nanoparticles, to provide antibacterial properties.

FIG. 15A illustrates an embodiment of a catheter tip. FIG. 15Billustrates another embodiment of a catheter tip;

Referring to FIGS. 15A-15B, it is shown that embodiments of cathetersmay be used with ports as described in U.S. Pat. No. 7,004,923, which isincorporated in its entirety by reference, may be used. The catheter isgenerally described herein and in this embodiment includes a distalportion as shown via reference number 1550. The distal portion 1550includes an outer tube 1552. A plurality of fluid ports 1556 areprovided within the tube 1552, preferably throughout the entirecircumference thereof. The portion of tube 1552 that includes the ports1556 defines the infusion section of catheter 1550. An access for thecannula is provided within the distal tip 1558 of the tube 1552.Moreover, the distal end portion may a preformed shape as describedherein.

The tube 1552 may be formed from any of a variety of suitable materials,giving due consideration to the goals of non-reactivity to anatomicalsystems, such as nylon, polyimide, Teflon, biodegradable materialspreviously discussed and other materials known to those skilled in theart, giving due consideration to the goals of non-reactivity toanatomical systems, flexibility, light-weight, strength, smoothness, andsafety. In a preferred configuration, the tube 1552 is preferably a 20gauge catheter tube, having inside and outside diameters of 0.019 inchesand 0.031 inches, respectively. The ports 1556 of tube 1552 arepreferably about 0.015 inches in diameter and provided at equally spacedaxial positions along the tube 1552. The holes 1556 are preferablyarranged so that every hole is angularly displaced about 120° relativeto the longitudinal axis of the tube 1552, from the angular location ofthe previous hole. Other angular displacements are possible, e.g., in arange from about 5° to about 180° relative to the longitudinal axis ofthe tube.

The axial separation between adjacent ports 1556 is preferably withinthe range from about 0.1 inches to 0.3 inches, and more preferably about3/16 inch. Also, the infusion section can have any desirable length butis preferably about 0.5 to 20 inches long, and more preferably about 10inches long. This configuration results in a thorough, uniform deliveryof fluid throughout a generally linear segment of the wound area. Ofcourse, the ports 1556 may be provided in any of a variety ofalternative arrangements. In addition, each port 1556 or only a portionof the ports may be surrounded with a marker 1551 to permitvisualization, e.g., radiopaque, echogenic, and combinations of thesame.

FIG. 15B illustrates a catheter which is generally described herein andin this embodiment includes a distal portion as shown via referencenumber 1553. This embodiment is better suited for relatively high flowrate delivery of fluid to a region within an anatomical system. Catheter1550 includes a tube 1552 having a plurality of ports 1556 of increasingsize. In particular, the more distal ports are larger in diameter thanthe more proximal ports. The position of the ports 1556 on the tube 1552defines the length of the infusion section of the catheter 1550. Theinfusion section can have any desired length. The proximal end ofcatheter 1550 is connected to a fluid supply, and a guidewire and/orguidewire lumen may also be provided for aiding in the insertion ofcatheter 1550 into the anatomy. One or more marking lines 1555, 1559 andmarkers 1561 may surround a port 1556 to permit visualization, e.g.,radiopaque, echogenic, and combinations of the same.

As discussed above, for high or low pressure fluid delivery, portsnearer to the distal end of a catheter tube generally have increasedflow resistance compared to ports nearer to the proximal end of thetube. Also, the fluid flowing through the more distal holes experiencesa greater pressure drop. Consequently, there is generally a greater flowrate of fluid through the more proximal holes, resulting in non-uniformfluid delivery. In contrast, catheter 1550 advantageously providessubstantially uniform fluid delivery through substantially all of theports 1556, under relatively high flow rate conditions. This is becausethe larger size of the more distal holes compensates for their increasedflow resistance and pressure drop. In other words, since the more distalholes are larger than the more proximal holes, there is a greater flowrate through the more distal holes than there would be if they were thesame size as the more proximal holes. Advantageously, the holes 1556 areprovided in a gradually increasing size which results in substantiallyuniform fluid delivery. In addition, the ports 1556 may be sized so thatthey combine to form a flow-restricting orifice. Moreover, the distalend portion may a preformed shape as described herein.

FIG. 16 illustrates an embodiment of a single handed catheter advancingdevice.

Referring to FIG. 16, the invention is a single handed catheteradvancing device and is generally depicted as reference number 400. Thesingle handed device 400 allows a catheter to be advanced into a patientsingle handed. This device is not limited to only catheters describedherein, but may be used with conventional needle over the catheterconfigurations. The device 400 includes a body 428 having free revolvingrollers 424. The free revolving rollers 424 can be operated singlehandedly by the operator by placing the thumb of the operator on thefree revolving rollers 424 and turning the rollers 424 which can insertor remove the catheter 402 depending upon the direction the rollers 424are being turned. The catheter 402 is inserted through the catheterinsertion opening 420 which is located at the end of the body 428. Thefree revolving rollers 424 advance the catheter 402 into the needle 404.The free revolving rollers 424 may include rubber grippers on the roller424. The rubber grippers can be made of any suitable material, includingbut not limited to nylon, rubber, teflon, polyamide, polyfiline, otherpolymers and the like, or combinations thereof. The body 428 is alsoconnected to a luer 405, such as a swivel male luer. The luer 405 can beconnected to a needle hub 421, which is also connected to the needle 404either permanently or temporarily. For example, the luer 405 may containthreads that may engage with threads on the needle hub 421. The needlehub 421 can disconnect from the luer 405. In addition, the luer 405 maybe an integral portion of the body 428.

The device operates to advance the catheter 402 into the needle 404 withone hand, while leaving the other hand of the operator free to performother tasks, such as attach and operate a nerve stimulator or use anultrasound to locate a nerve bundle. The device may also be used with anant-restriction member and/or supplemental catheter as described herein.The operator introduces the needle 404 to the patient. The single handeddevice 400 may be connected as the operator introduces the needle 404 tothe patient, or it may be attached at a later time. Once the needle 404is in place, a catheter 402 may be introduced into the hollow needle404. The device 400 contains channel 429, which directs the catheter 402introduced to the device through the opening 420 through the luer 405,into the needle hub 421 and eventually into the needle 404. The operatorcan control the advancement of the catheter 402 using the rollers 424 onthe body 428. Once the catheter 402 is in place, the operator may removethe needle 404 and device 400 in a single motion by sliding the needle402 attached to the device 400 over the catheter 402. Alternatively, theoperator may remove the needle 402 and device 400 in two steps by firstdisconnecting the device 400 from the needle 404 at the needle hub 421,then removing the needle 404 from the patient, while leaving thecatheter 402 in place. The catheter 402 may then be joined to anapparatus, such as an infusion pump.

FIG. 17A illustrates a single handed catheter advancing device accordingto another embodiment. FIG. 17B illustrates a perspective view of asingle handed catheter advancing device illustrated in FIG. 17A. FIG.17C illustrates a perspective view of a single handed catheter advancingdevice illustrated in FIG. 17A with a catheter;

As illustrated in FIGS. 17A-17C, the device is generally depicted asreference number 500. The device 500 includes a catheter insertionopening 520 located adjacent to one of the free revolving rollers 524 ofthe body 528 and used to advance the catheter 502 through a luer 505 andinto a needle or cannula. A handle 530 may be permanently or temporarilyattached to the body 528 using any suitable means. The handle 530 may beergonomical and made of any suitable material. Furthermore, the handle530 may include indents for fingers—in particular it may include agroove to receive a portion of the thumb of the user. The handle 530 maybe tapered, may vary in length, and may vary in diameter or size. In analternative embodiment, a catheter insertion opening 520 may be locatedanywhere on the body of the single handed catheter. By way of example,the catheter insertion opening 520 may be located near the end of thehandle 530, which is similar to the configuration of FIG. 16. In thisconfiguration, the opening 520 is aligned with a central-axis of thehandle 530.

The body 528 is shown with the free revolving rollers 524 and isadjacent to the catheter insertion opening 520, which is located on thebody 528 adjacent to the free revolving rollers 524. Luer 505 may beused to attach the device 500 to a needle, through the needle hub 521.

In one embodiment, the catheter 502 is advanced through the catheterinsertion opening 520 of the body 528, which is adjacent to one of thefree revolving rollers 524. The cannula or needle 504 is attached to thedevice 500 through the luer 505, which is connected to the needle hub521. The catheter advances through the luer 505, through the needle hub521, and into the needle 504.

FIG. 18 illustrates an operational systematic view of the single handedcatheter advancing device 500 as illustrated in FIG. 17C. The device 500includes a needle 504 which remains external to the patient. The sheath504 is inserted through the needle hub 521 and the needle 504. Theneedle hub 521 is connected to the device 500 through a luer 505.

Nerve(s) 511 lying in deep in tissue below the exterior surface of thepatient are targeted to receive a pharmacological agent. A subcutaneousdistal portion of the needle 508 is shown positioned in close proximityto the targeted nerve(s) 511, e.g., nerves of the brachial plexus. Anerve stimulator (not shown) may be used to stimulate the nerve(s) 511.A nerve stimulator conducting wire 577 is electrically coupled between anerve stimulator (not shown) and needle 504 to provide the requisitesingle to the needle 504. Once the needle is in place, the catheter 502may be advanced through the needle. The needle may be removed and thehub 521 disconnected from the luer 505.

Next, an infusion pump may be filled with a pharmacological agent, e.g.,medication such as a nerve block, and the pump is connected to theapparatus. The pump can include ON-Q® C-bloc-Continuous Nerve BlockSystem by I-Flow Corporation, PainPump 1, PainPump 2, PainPump 2BlockAid by Stryker Corporation, and GoPump® or GoBlock® by Symbios andmay be any of the embodiments previously explained and described withreference to FIGS. 7-14. Of course any described catheter herein mayalso be used with devices of FIGS. 15-18.

The devices of FIGS. 15-18 aid a user in single handedly advancing andretracting a catheter to a desired location, e.g., nerve location.Thereby, the user may use the other free hand to aid with visualization.These devices may be used with conventional catheter-through-needlesystems. It is also noted that these devices are not required for singlehanded operation advancement, retraction of a catheter and/or cannula,but rather further aid a user in that regard.

FIG. 19A illustrates an embodiment of a solid introducer. FIG. 19Billustrates the solid introducer of FIG. 19A in a catheter.

Referring to FIGS. 19A-19B, the solid introducer catheter system isgenerally depicted as reference number 600. The system includes a solidintroducer 604. The solid introducer 604 may be used with the catheter602 or other catheters described herein. The solid introducer 604 fitswithin the catheter 602. The catheter 602 may be a reinforced catheterand may include at least one or a plurality of ports 607 near the distaltip of the catheter 602. Ports as described anywhere herein, e.g., inFIGS. 15A-15B, may also be used.

On the proximal end of the catheter 602 is a catheter hub 621. The solidintroducer 604 may also include an optional curved tip 603 which may beused as a cutting surface to insert the solid introducer catheter system600 into the patient. The solid introducer 604 may include an optionalstimulator connection site 609 wherein a stimulator (not shown) may beconnected through the solid introducer 604. The optional stimulatorconnection site 609, when inserted into the catheter 602 may rest on thecatheter hub 621 which controls the depth of insertion of the solidintroducer 604 through the catheter 602 such that the distal tip 603 ofthe solid introducer 604 protrudes from the tip of the catheter 602.Furthermore, the stimulator connection site 609 is adjustable along thelength of the solid introducer 604. Additionally, a needle hub 605 maybe used by the operator to pull the solid introducer 604 from thepatient once the catheter 602 is in place. Once the solid introducer 604has been removed from the catheter 602, the catheter hub 621 may be usedto connect the catheter 602 to the remaining system or other device.

FIG. 20 illustrates another embodiment of the present invention, whichis a hollow introducer catheter system 700. In this system, theintroducer 704 is hollow. The hollow introducer 704 is advantageousbecause it allows a guidewire 734 to sit within the introducer 704 whichsits inside of the catheter 702. The catheter 702 may be a tightly woundwire coil through the majority of the body of the catheter 702, but nearthe distal tip of the catheter 702 becomes a loosely wound wire whichwill allow for flexibility. The distal end of the catheter 702 may alsoinclude at least one or a plurality of ports 736. The introducer hub 705rests upon the catheter hub 721, which controls the depth of theintroducer 704 within the catheter 702. Once the introducer 704 has beenremoved, the catheter hub 721 may be used to connect the catheter 702 tothe remaining system or other device.

FIG. 21 illustrates an embodiment of a guidewire.

Referring to FIG. 21, the guidewire 734 may be used with catheters asdescribed herein. In one embodiment, the guidewire 734 is helpful forpositioning the catheter 702 and/or stimulating the nerve bundle in thepatient. Optionally, the guidewire 734 may be equipped with a flexiblepreformed tip 736 which allows for directional advancement of thecatheter. The flexible preformed tip may be straightened out to passthrough a needle or catheter, but will return to its preformed shapeonce it has exited the needle or catheter. In some embodiments, theposition of the catheter follows the preformed shape of the guidewireonce the guidewire is withdrawn. Near the guidewire hub 721, there is adirectional tab 738 which corresponds to the direction and location of aflexible tip 736 on the guidewire 734. A stimulator (not shown) may alsobe attached to the directional tab 738. The guidewire 734 may be usedeither in the hollow introducer 704 or in the catheter 702.

FIG. 22A illustrates another embodiment of a hollow introducer in acatheter with a sleeve. FIG. 22B illustrates another embodiment of aguidewire in a catheter with a sleeve.

Referring to FIGS. 22A and 22B, a sleeve 740 used in the catheter system700 which allows for the reinsertion of an introducer 704 into thecatheter 702 for repositioning of the catheter 702. That is, the sleevewill prevent tears in an external or internal surface of a catheter 702upon reinsertion or repositioning of the catheter 702 when a cannula isrequired to reposition the catheter by advancing through tissue. Thesleeve may also be utilized to prevent kinking of the catheter.

FIG. 23 illustrates an embodiment of the continuous anesthesia nerveconduction apparatus. The apparatus is generally depicted as referencenumber 2200. The apparatus 2200 includes an introducer 2204, which maybe a solid introducer or a hollow introducer, configured to fit within acatheter 2202 with at least one port 2214. An insert 2219 abuts andengages between the introducer end 2207 and the catheter hub 2206. Theintroducer 2204 slides into the catheter 2202, through the catheter hub2206 and through the center of the insert 2219. The insert 2219 isconfigured, such that the user may access and connect a nervestimulation device to the exposed segment of the introducer 2204allowing for the introducer 2204 to become a stimulatable needle. Theinsert 2219 may contain threads or other type of fitting on either orboth sides that engage with the introducer end 2207 and/or the catheterhub 2206.

The catheter 2202 may include markings as described herein, e.g.,markings as described with reference to FIGS. 28A-28B. Moreover, thecatheter 2202 may include a preformed resilient distal portionconfigured to position the distal portion at least partially around anerve. The preformed resilient distal portion may be configured tominimize dislodgment of the catheter 2202 from a treatment situs.Optionally, the catheter 2202 may be configured to fixedly bend from afirst position to a second position with application of curved guidewireand curvature relative to a longitudinal axis of the catheter 2202 thecurvature may be in a range from about 1 degree to about 180 degrees,more preferably the curvature is a range from about 80 degrees to about110 degrees. The catheter 2202 may configured as described in FIGS.6A-6B or any embodiment described herein like with any other catheterdescribed herein.

FIG. 24 is a view of the insert 2219. The insert 2219 contains openings2223 which allows the introducer to fit through the insert 2219. Aportion of the insert 2223 may contain threads to engage with anexterior thread on the introducer 2207 which may hold the introducer2207 in place during use. Alternatively, the insert 2219 may be a slipfit, such that once the introducer 2207 is in place, it fits snuglywithin the insert 2219. In another embodiment, the insert 2219 containsthreads on the end that abuts the introducer end, and engages withthreads on a portion of the introducer. In another embodiment, theinsert 2219 contains threads or other fittings on the end that abuts thecatheter hub, which engages with threads on the catheter hub. In anotherembodiment, the insert 2219 contains threads on both ends. Once thecatheter is in place, the user may connect a nerve stimulation device tothe exposed segment of the introducer shaft to convert the introducerinto a stimulating needle for nerve localization.

In some embodiments, the insert 2219 contains at least one optionalopening 2221. The opening 2221 may be any shape or size and may provideaccess to the introducer through the insert 2219. In other embodiments,the insert 2219 is a solid piece, without any openings 2221. In stillother embodiments, the insert is tapered on one end such that thetapered end comes into contact with the introducer. The insert 2219 maybe connected to a stimulator in order to stimulate the introducer. Instill other embodiments, the insert 2219 may be ergonomical and mayinclude indents for fingers—in particular it may include a groove toreceive a portion of the thumb of the user. The insert 2219 may assistthe user to disconnect the introducer from the catheter with the use ofonly one hand.

The insert 2219 may vary in length and may be made of any suitablematerials. In some embodiments, the insert 2219 is made from a polymericmaterial. In other embodiments, the insert 2219 is made of anelectrically conductive material. In other embodiments, the insert 2219may be made of a polymeric material, which has been impregnated with anelectrically conductive material.

FIG. 25A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention infirst orientation. FIG. 25B illustrates the continuous anesthesia nerveconduction apparatus of FIG. 25A in a second orientation. FIG. 25Cillustrates a guidewire according to another embodiment of theinvention. FIG. 25D illustrates a guidewire according to anotherembodiment of the invention.

Referring to FIGS. 25A-25D, a continuous anesthesia nerve conductionapparatus is generally depicted as reference number 2500. The apparatus2500 includes an integrated guidewire with a needle to allow for singlehanded deployment of guidewire by advancing the tab on the needle hub.Also this apparatus reduces procedural steps by not having to detach thesyringe before advancing guidewire. The apparatus 2500 includes areinforced catheter 2502 over a cannula 2504 with an integrated hub2506. The catheter 2502 includes a port 2503. The hub includes aguidewire advancer 2508 configured to move a guidewire 2510 from a firstposition to a second position with activation from a user, e.g., a thumbof a user, as shown by the arrow. The catheter 2502 can slide off thecannula 2504. The guidewire 2510 may be configured with an angledgeometry 2512 at a distal tip to aid bending a distal portion of thecatheter 2502 around or partially around a nerve. The cannula 2504includes a lumen extend from proximal portion to a distal portion toallow fluid transfer. The catheter and/or cannula may include markingsas described here to aid with location of each to a desired treatmentsitus. The guidewire may also be a steerable guidewire as known in theart.

FIG. 26A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 26B illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus according to FIG. 26A.

Referring to FIGS. 26A-26B, a continuous anesthesia nerve conductionapparatus is generally depicted with reference to number 2600. In thisembodiment, an integrated catheter with a dual lumen is illustrated. Theapparatus 2600 includes a catheter 2602 having a first lumen 2604 and asecond lumen 2606. The first lumen 2604 and second lumen 2606 merge toone lumen 2607 at a distal portion of the catheter. The first lumen 2604extends from a proximal portion to a distal portion of a hub 2608. Aport 2610 is in fluid communication with the first lumen 2604. The hub2608 includes a guidewire advancer 2508 configured to a move a guidewire2510 from a first position to a second position with activation from auser, e.g., a thumb of a user.

The guidewire 2510 may be configured with an angled geometry 2512 at adistal tip to aid bending a distal portion of the catheter 2502 aroundor partially around a nerve. The catheter 2602 in this embodiment isconfigured to puncture a skin directly and has functionalcharacteristics as a cannula. The catheter may include a side port orplurality of ports. The catheter may include markings as described hereto aid with location of each to a desired treatment situs. Optionally,an additional removable sleeve may be utilized over the catheter 2602.

FIG. 27A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 27B illustrates a cross-sectional view of the continuous anesthesianerve conduction apparatus according to FIG. 27A.

Referring to FIGS. 27A-27B, a continuous anesthesia nerve conductionapparatus is generally depicted with reference to number 2700. In thisembodiment, an integrated catheter with a dual lumen is illustrated. Theapparatus 2700 includes a catheter 2702 having a first lumen 2704 and asecond lumen 2706. The first lumen 2704 and second lumen 2706 extendfrom a proximal portion to a distal portion of a hub 2708. A port 2710is in fluid communication with the first lumen 2704. The hub 2708includes a guidewire advancer 2508 configured to move a guidewire 2510from a first position to a second position with activation from a user,e.g., a thumb of a user.

The guidewire 2510 may be configured with an angled geometry 2512 at adistal tip to aid bending a distal portion of the catheter 2502 aroundor partially around a nerve. The catheter 2702 in this embodiment isconfigured to puncture a skin directly and has functionalcharacteristics as a cannula. The catheter may include a side port orplurality of ports. The catheter may include markings as described hereto aid with location of each to a desired treatment situs. Optionally,an additional removable sleeve may be utilized over the catheter 2702.

FIG. 28A illustrates a distal end of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 28B illustrates a distal end of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.

Referring to FIG. 28A, a distal portion 2800 of a catheter 2802 includesa first port 2804, second port 2806 and third port 2808. The first port2804 and second port 2806 are oriented on opposite side of the catheter2802. A plurality of markings 2810, 2812, 2814, 2816, 2818, and 2820 areconfigured to aid in the angular orientation and longitudinalorientation of the catheter and ports 2804, 2806, and 2808. Anycombination of markings may be used, e.g., more or less may be utilized.The markings may have different geometric configurations to also aidwith orientations. The markings may include an echogenic material,radiopaque material, combination of the same and the like. In addition,the catheter may include markings as described with reference to U.S.Patent Application Publication 2012/0059308, which is herebyincorporated by reference as if fully set forth herein.

Referring to FIG. 28B, the distal portion 2800 includes two ports, 2804and 2808 and at least one marking 2810 positioned immediately proximallyadjacent to the port 2804. The marking 2804 is utilized to aid in portlocation and utilized to position the port 2804 to a desired treatmentsitus, e.g., a nerve.

FIG. 29A illustrates an exemplary view of an apparatus according to anembodiment of the invention. FIG. 29B illustrates an exemplary view of acannula according to the apparatus of FIG. 29A.

Referring to FIGS. 29A-29B, a continuous nerve conduction apparatus isgenerally depicted as reference number 2900. The apparatus 2900 includesa catheter 2904 and a cannula 2902. The catheter 2904 is over thecannula 2902 and the cannula 2902 is slidably adapted to move though alumen (not shown) of the catheter 2904. The cannula 2902 includes alumen 2903 extending from a proximal region to a distal region. In apreferred embodiment, the lumen 2903 is configured to have a constantdiameter from the proximal region to the distal region. The cannula 2902and catheter 2904 may be constructed to include any features asdescribed herein. Moreover, in one embodiment the cannula is describedwith reference to U.S. Patent Application Publication No. 2011/0112511,which is herein incorporated by reference as if fully set forth herein.The cannula 2902 may be a Touhy needle, Crawford needle, Hustead Needle,Sprotte needle, Whitacrea needle, Quincke needle, or other medicalneedles. In a preferred embodiment, the gauge of the needle is in arange from about 6 to about 26 and more preferably the gauge of theneedle is in a range from about 18 to about 20.

The cannula 2902 and/or catheter 2904 include a change of diameter at adistal end portion 2908. The distal end portion of the cannula 2902and/or catheter 2904 has a smaller diameter than a more proximal regionof the cannula 2902 and/or catheter 2904. In one embodiment, thediameter changes from a larger diameter to a smaller diameter graduallyat a taper at region 2905. In an alternative embodiment, the distalregion of the cannula 2902 and/or catheter 2904 has a larger diameter ascompared to a region more proximal of the cannula 2902 and/or catheter2904.

The catheter 2904 includes at least one side port 2906, which isarranged in the distal region of the catheter 2904. At least one sideport 2906 is configured to allow a pharmacologic agent to exit when theend port 2907 is occluded or partially occluded. Moreover, the side port2906 may include any geometry or number as described herein. In apreferred embodiment, the side port 2906 includes four side portsarranged along the same axis of the catheter and uniformly spaced fromeach other. The distal end of the cannula 2902 includes a distal endport 2907 configured to allow a pharmacologic agent to exit.

The change from a larger diameter to a smaller diameter or vice versamay be a gradual taper having any type of shape, e.g., a linear tapershape, non-linear taper shape or a sharp taper shape. The sharp taperincludes angle change from about 85 degrees to about 95 degrees from acentral axis of the catheter. Moreover, the change from a largerdiameter to a smaller diameter may be at any angle from the central axisof the catheter in a range from about 1 degree to about 90 degrees;preferably the taper is at an angle ranging from about 25 degrees toabout 75 degrees, and more preferably the taper is at an angle rangingfrom about 35 to about 55 degrees.

The change in diameter size is configured to promote visualization underexternal imaging, e.g., ultrasound imaging or other imaging technology.The smaller or larger diameter change allows one to pin-point the changeof diameter under ultrasound imaging without the need of an echogenicmaterial or other type of visualization material. The diameter changemay be in a range from about 0.1 gauge to about 5 gauge or greater, in apreferred embodiment the diameter change is in a range from about 2gauge to about 4 gauge, and in a more preferred embodiment the diameterchange is about a 2 gauge change. In a preferred embodiment, the regionof catheter 2905 extending past the diameter change is in a range from0.1 cm to about 4 cm, more preferably in a range from 0.5 cm to 2 cm,and most preferably in a range from about 1 cm to 1.8 cm. Moreover, thelocation of the lateral port 2906 can be determined as it is placedadjacent the diameter change or taper.

FIG. 29C illustrates an exemplary view of a distal end region of acatheter according to the apparatus of FIG. 29A according to anotherembodiment of the invention. FIG. 29D illustrates an exemplary view of adistal end region of a catheter according to the apparatus of FIG. 29Aaccording to another embodiment of the invention. FIG. 29E illustratesan exemplary view of a distal end region of a catheter according to theapparatus of FIG. 29A according to another embodiment of the invention.

Referring to FIG. 29C, the distal end region 2910 of the catheter 2904includes a straight portion. The cannula 2902 in this embodiment alsoincludes a distal end region being straight, i.e., with no curvature.

Referring to FIG. 29D, the distal end region of the catheter 2904includes a curved region 2912 in a range from about 85 degrees to about95 degrees. The cannula 2902 may also have a curved region at distal endregion, e.g., in a range from about 1 degree to about 10 degrees orgreater. In this embodiment, the catheter includes a portion having acurvature configured as a preformed memory shape as described herein.

Referring to FIG. 29E, the distal end region of the catheter 2904includes a curved region 2914 in a range from about 185 degrees to about175 degrees. The curved region may be configured in a range from about 5degrees to about 185 degrees. In operation, this curved region isconfigured to provide a radial spread of local anesthetics out of one ormore side ports 2906 and/or distal end port 2907. Neural structures arefrequently cylindrical in shape and by positioning the catheter to covera large area of the neural structure the pharmacological agent asdispensed surrounds a nerve providing for more efficacy of the agent.The cannula 2902 may also have a curved region at distal end region,e.g., in a range from about 1 degree to about 10 degrees or greater.

FIG. 30A illustrates a perspective view of a cannula according toanother embodiment of the invention. FIG. 30B illustrates a top view ofa cannula according to FIG. 30A. FIG. 30C illustrates an enlarged viewof a cannula according to FIG. 30A.

Referring to FIGS. 30A-30C, a cannula is generally depicted as referencenumber 3000. The cannula 3000 is configured to be inserted through alumen of a catheter. The cannula 3000 includes a shaft 3000 having alumen extending form a proximal end to a distal end. The proximal end iscoupled to a hub 3004 and the distal end has a Touhy tip needle or othermedical needle.

The gauge of the cannula is in a range from about 10 gauge to about 26gauge. In a preferred embodiment, the gauge is in range from about 18gauge to about 20 gauge. The length of the cannula can be in a rangefrom about 5 cm to 30 cm or greater. In a preferred embodiment, thelength of the cannula is one of 7 cm, 15 cm, and 20 cm. The hub 3004includes at least one alignment mark 3006. The alignment mark 3006 maybe any type of notation or markings configured to determine anorigination of a distal end portion of the cannula 3000. The hub 3004includes a fitting 3005 configured to receive a syringe or other device.

The cannula 3000 includes a Touhy tip 3008. The Touhy tip 3008 has aslight curve portion at the end of the shaft 3002. The curvedorientation is indicated by the alignment mark 3006. In this embodiment,the alignment mark 3006 is an arrow which indicates the curved portionof the Touhy tip is coming out of the page.

FIG. 31A illustrates a cross-sectional view of a cannula according toanother embodiment of the invention. FIG. 31B illustrates a distal endview of the cannula of FIG. 31A. FIG. 31C illustrates an exploded viewof a hub of FIG. 31A.

Referring to FIG. 31A, the cannula is generally depicted as referencenumber 3100. The cannula 3100 includes a shaft 3102 and is configured tobe inserted through a lumen of a catheter. The cannula 3100 includes ashaft 3102 having a lumen extending form a proximal end to a distal end.The proximal end is coupled to a hub 3104 and the distal end has a Touhytip 3106 or is configured as another needle as described herein. The hub3104 includes at least one alignment mark (not shown). The cannula isconfigured to stimulate a nerve as known in the art. A conductiveelement 3108 is configured to transmit electrical activity used toactivate a nerve via the cannula shaft 3102 to a distal portion of thecatheter 302 and cannula 304. In a preferred embodiment, the electricalactivity is generated by a nerve stimulator generator (not shown), e.g.,Stimuplex® HNS11 Peripheral Nerve Stimulator by B. Braun, Stimuplex DigRC by B. Braun, MultiStim VARIO by Pajunk, and EzStim® stimulator byLife-Tech International. In a preferred embodiment, the embeddedconductive element 314 is an embedded wire.

Referring to FIGS. 31B and 31C, the hub 3104 is constructed from aproximal hub portion 3101, a conductive element 3108, and a distal hubportion 3103. The conductive element 3108 is an integral unit or solidunit formed from a conductive material. The conductive material isconstructed from a conductive material. The conductive element 3108includes a first tab 3105 and a second tab 3107 coupled to a cylindricalunit 3109. The proximal hub portion 3101 abuts the first tab 3105 andsecond tab 3107 and the distal hub portion 3103 abuts the first tab3101, second tab 3105 and covers a proximal hub portion 3101.

In one embodiment, the conductive element 3108 and is formed from asingle mold unit. The cylindrical unit 3109 includes a lumen configuredto receive the cannula shaft 3102. Optionally, the first tab 3105 andsecond tab 3207 includes one or more holes (not shown) for acceptance ofa clip of the nerve stimulator attachment mechanism. The shaft 3102 alsoincludes an electrically insulated portion 3111 formed with aninsulating coating such as thermoplastic coating.

The alignment mark includes any type of notation or markings configuredto determine an origination of a distal end portion of the cannula 3100.In this embodiment, the Touhy tip 3106 has a slight curve portion at theend of the shaft 3102. The curved orientation of the Touhy tip isindicated by the alignment mark such as an arrow. The arrow whichindicates the curved portion of the Touhy tip is coming out of the page.The gauge of the cannula is in a range from about 10 gauge to about 26gauge. In a preferred embodiment, the gauge is in range from about 18gauge to about 20 gauge. The length of the cannula can be in a rangefrom about 5 cm to 30 cm or greater. In a preferred embodiment, thelength of the cannula is one of 7 cm, 15 cm, and 20 cm.

FIG. 32A illustrates an exemplary view of a catheter according toanother embodiment of the invention. FIG. 32B illustrates an enlargedview of section B-B of the catheter of FIG. 32A. FIG. 32C illustrates anenlarged cross-sectional view of a distal portion of the catheter ofFIG. 32A. FIG. 32D illustrates an end view of the catheter of FIG. 32A.FIG. 32E illustrates an enlarged view of a hub according to the catheterof FIG. 2A.

Referring to FIGS. 32A-32E, a catheter is generally depicted asreference number 3200. The catheter 3200 includes a hub 3202 on aproximal portion, a shaft 3204 and one or more lateral ports 3206 on adistal portion. The shaft 3204 further includes markings 3208 configuredto indicate the length the catheter. The markings 3208 are configured atpredetermined increments in a range from about 1 cm to about 1 cm toabout 10 cm or greater.

The hub 3202 includes a first tab 3210 and a second tab 3212 configuredto be adhered to a portion of a patient. The first tab 3210 and thesecond tab 3212 include an adhesive on side configured to adhere to apatient. The adhesive may include a removable portion protecting theadhesive prior to first use. A distal end of the catheter includes ataper at an angle of about thirty degrees relative to a central axis.The catheter may optionally be reinforced with a secondary material inorder to increase stiffness of the catheter and substantially preventkinking. The reinforcement may be constructed from a metal, polymer,thermoplastic and combinations of the same.

The shaft 3204 includes a plurality of lateral ports 3206 arranged at adistal end portion of the catheter. The spacing between adjacent lateralports are uniformly spaced and offset from each other at an angle arounda circumference of the shaft 3204. In this embodiment, the angle betweenlateral ports is about 120 degrees as shown in FIG. 32D. The diameter ofeach lateral port may be identical to an adjacent lateral port. Thediameter is in a range from about 0.005 inches to about 0.05 inches orgreater. Optionally, the hub 3202 includes an alignment mark 3216configured to show an orientation of the lateral port. In oneembodiment, there may be a plurality of alignment marks on the hub whereeach alignment mark is configured to depict the orientation of eachlateral port, respectively.

FIG. 33 illustrates an exemplary view of a catheter according to anotherembodiment of the invention.

Referring to FIG. 33, a catheter is generally depicted as referencenumber 3300. The catheter 3300 includes a hub 3302 on a proximal portionof a shaft 3304 and one or more lateral ports 3306 on a distal portionof the shaft 3304. The shaft 3304 further includes markings 3308configured to indicate the length the catheter as described herein. Thehub 3302 includes a first tab 3310 and a second tab 3312 configured tobe adhered to a portion of a patient. The first tab 3310 and the secondtab 3312 are described herein.

The catheter includes a curved portion 3314 on the distal portion of theshaft 3304. The curved portion is preformed into the catheter as amemory shape. When a cannula is in the catheter the catheter distal endis straight and upon removal of the cannula the catheter is curved tothe preformed shape. The shape of the curve may be at any angle asdescribed herein. In a preferred embodiment, the curvature has a radiusof about 0.5 inches.

FIG. 34A illustrates a top view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 34B illustrates a bottom view of a continuous anesthesia nerveconduction apparatus according to FIG. 34A. FIG. 34C illustrates across-sectional view of the continuous anesthesia nerve conductionapparatus according to FIG. 34A.

Referring to FIGS. 34A-34C, the apparatus is generally depicted asreference number 3400. The apparatus 3400 includes a cannula 3402 and acatheter 3404. The cannula 3402 and hub 3408 are described with detailwith respect to FIGS. 31A-31C. The cannula 3402 is arranged through alumen of a catheter 3404. The cannula 3402 includes a shaft 3406 havinga lumen coupled to a hub 3408 and at least one alignment mark 3410configured to indicate the orientation of a curvature of a distal end ofthe cannula as described herein. The hub 3408 includes a conductiveelement 3412 configured to be attached to a nerve stimulator asdescribed herein.

The catheter 3404 is described in further detail with regard to FIGS.32A-32C. The catheter 3404 includes a hub 3414 on a proximal portion ofa shaft 3416 and one or more lateral ports 3418 on a distal portion ofthe catheter 3402. The shaft 3416 of the catheter 3402 includes markings3420 configured to indicate the length the catheter. The hub 3414includes at least one alignment mark 3426 configured to indicate theorientation of a lateral port 3418 as described herein.

The hub 3408 of the cannula 3402 and hub 3414 of the catheter 3404 areconfigured to fit together in substantially locked configuration suchthat there is continuous lumen extending between and through both hubs.The locked configuration substantially prevents individual rotation ofeither the catheter 3404 or cannula 3402, thereby allowing the catheterand cannula to be utilized as one unit. In an alternative embodiment,the portion where the hubs are in contact with each include male andfemale notches arranged at predetermined orientations on respectivecontact surfaces of the hubs. These notches may be arranged in acircular pattern along an axis of the hub at various degrees, e.g., 30degrees, 60 degrees, 90 degrees, 120 degrees, 150 degrees, and 180degrees. The notches are configured to permit offset rotation of thecatheter relative to the cannula at each predetermined orientation. Whenthe male and female notches are engaged the catheter and cannula are insubstantially locked configuration.

The hub 3414 includes a first tab 3422 and a second tab 3424 configuredto be adhered to a portion of a patient. The first tab 3422 and thesecond tab 3424 include an adhesive on side configured to adhere to apatient. The adhesive may include a removable portion protecting theadhesive prior to first use. The end of the catheter includes a taper atabout 30 degrees. The catheter may optionally be reinforced with asecondary material, e.g., metal, polymer, thermoplastic and the like inorder to increase stiffness.

FIG. 35A illustrates a perspective view of an extension set according toanother embodiment of the invention. FIG. 35B illustrates a side view ofthe extension set of FIG. 36A.

Referring to FIGS. 35A-35B, the extension unit is generally depicted asreference number 3500. The extension unit 3500 includes a fitting 3502coupled to a tubing 3506 coupled to another fitting 3510. The fittingsof this embodiment may include a luer connector, e.g., a male luerconnector, female luer connector, and/or luer-lock connector. In apreferred embodiment, the fitting 3502 is luer lock male cap connectorconfigured to be releasably coupled to a hub of a catheter and/orcannula, e.g., catheter hub 3414 or cannula hub 3408. A flexible tubing3506 is connected to the fitting 3502 and a male luer connector 3510.

The fitting 3502 and/or tubing 3506 includes a first tab 3502 and asecond tab 3504 configured to be adhered to a portion of a patient. Thefirst tab 3502 and the second tab 3504 include an adhesive on one sideconfigured to adhere to a patient. The adhesive may include a removableportion protecting the adhesive prior to first use. The fitting 3510and/or tubing 3506 also include a label 3508. In a preferred embodiment,the label 3508 is a warning label to indicate the type of catheter suchas a nerve catheter versus an intravenous (iv) catheter. The label 3508and tabs 3504 are integral or built into the extension set 3500. Thelength of the tubing is no more than about five inches and in preferredembodiment about three inches in length. This short tubing lengthprovides for an enhanced ease of use and minimizes contamination,thereby allowing a user to operate the system with one handed operation.

FIG. 36A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 36B illustrates a graph of an interference fit according to theapparatus of FIG. 36A.

Referring to FIGS. 36A-36B, the apparatus is generally depicted asreference number 3600. The apparatus 3600 includes a catheter 3602 andcannula 3604. A distal portion of the catheter may have a curvature orno curvature as described herein. The cannula 3604 may include a Touhytip or other needle as described herein. In this embodiment, thecatheter 3602 has a lumen extending from proximal portion to a distalend. The distal portion of the catheter may also include side ports (notshown) as described herein. An inside diameter of the lumen of thecatheter 3602 decreases along a distal portion to the catheter as shownin FIG. 36B. This decrease allows for a resistant fit or interferencefit of the cannula 3604, thereby requiring the user to apply anincreased force to extend the cannula 3604 out a distal end of thecatheter 3602. The decrease of the inside diameter may be linear,non-linear or any combination of the same.

Referring to FIG. 36B, the graph includes the diameter of an insidediameter 3608 of a lumen of the catheter and outside diameter 3610 ofthe cannula on an x-y graph. The x-axis of the graph depicts a length[cm] of the catheter 3602 and/or cannula 3604 and the y-axis of thegraph depicts a diameter [cm]. As shown, the inside diameter 3608 of thelumen of the catheter 3602 decreases as it approaches a distal endportion of the catheter 3602. The outside diameter 3610 of the cannulais static or constant as shown in the graph. In one embodiment, thedistance delta 3612 between the inside diameter of the catheter lumenand outside diameter of the cannula is in a range from about 0.1 mm toabout 0.0001 mm. In a preferred embodiment, the distance delta is lessthan about 0.5 mm and may be about 0 mm.

This embodiment produces an interference fit between the cannula and thecatheter, thereby permitting the cannula and the catheter to act as onesolid unit when used. In one embodiment, the materials of the catheterinclude a thermoplastic material that allows for some expansion to addin the interference fit. This interference fit is configured to minimizeor eliminate any gap to between the distal end or distal end portions ofthe cannula and the inside diameter of the catheter, thereby minimizingthe probability that the catheter compresses, bunches, and/or snags upontissue of a patient. In a preferred embodiment, the distal most portionof the catheter is angled or beveled as described with reference to FIG.32B.

FIG. 37A illustrates a perspective view of a continuous anesthesia nerveconduction apparatus according to another embodiment of the invention.FIG. 37B illustrates a catheter according to another embodiment of theinvention. FIG. 37C illustrates an anti-restriction member according toanother embodiment of the invention.

Referring to FIGS. 37A-37C, the apparatus includes a cannula 3702, acatheter 3704, and an anti-restriction member 3706. The anti-restrictionmember 3706 is configured to be inserted into a lumen of the catheter3704. The anti-restriction member 3706 is conductive such that it can beused as a nerve stimulator. Optionally, a portion of the member 3706 isinsulated with a coating (not shown).

In this embodiment, the catheter 3704 includes a hub 3708 and a flexibletubing 3710 having a lumen that extends from a proximal end to a distalend. The lumen is configured to deliver a pharmacological agent to adesired treatment situs. The flexible tubing 3710 can kink or bend,thereby preventing fluid flow through the lumen. The flexible tubing3710 includes one or more lateral ports 3712 at distal end portion ofthe catheter 3704. In one embodiment, the hub 3708 includes an alignmentmark configured to show the orientation of the lateral port 3712 asdescribed herein.

The cannula 3702 includes a shaft 3714, a hub 3716, a conductiveconnector 3718 and an alignment mark (not shown) as described withreference to FIGS. 31A-31C and related text. The cannula 3702 isconfigured to be inserted into the catheter 3704. Both the cannula 3702and the catheter 3704 are configured to be inserted into a patient as asingle unit. The catheter 3702 and the cannula 3704 may be configuredwith an interference fit as described with reference to FIG. 36A-36B andrelated text.

After insertion the cannula 3702 is removed from the catheter 3704.Optionally, an anti-restriction member 3706 may be inserted into thecatheter 3704. The anti-restriction member 3706 includes a hub 3722, astimulation attachment 3724, and a fitting 3725. The anti-restrictionmember 3706 includes an element 3726 that enables fluid flow to continuethrough the lumen of the catheter 3704 when inserted. In addition, theelement 3726 is configured to prevent kinking of the catheter andprovide patency of the lumen catheter 3704. In this embodiment, theelement 3726 is constructed from a conductive material and into ageometric configuration to preserve patency of the lumen of the catheter3704.

The geometric configuration can include a helix braided wire, a spirallaser cut hypo-tube, a stent like structure and combinations of thesame. Should kinking or bending occur when the anti-restrictive member3706 is positioned in the catheter 3704 the element 3728 can act as aflow element to allow fluid to flow even upon kinking or bending of thecatheter and element 3728.

In this embodiment, when the element 3726 is configured to be used as anerve stimulator, the element 3726 is sized such that a distal mostportion of the element 3726 extends past a distal end of the catheter3704. Moreover, tabs 3722, 3724 on the hub 3725 are configured to beattached to a nerve stimulator. The hub 3725 is also configured with afitting 3725. The fitting 3725 can include a luer connector, e.g., amale luer connector, female luer connector, and/or luer-lock connector.In a preferred embodiment, the fitting 3725 is configured to bereleasably attached to a syringe and/or a tubing of a pump.

FIG. 37D illustrates a catheter according to another embodiment of theinvention.

Referring to FIG. 37D, a catheter is generally depicted as referencenumber 3728. The catheter 3728 includes a rigid shaft 3730 having alumen extending from proximal end to a distal end and the shaft 3730 andis coupled to a hub 3732. The catheter 3728 does not include any lateralports and is configured to be inserted into a lumen of the catheter3704, thereby strengthening the shaft 3710 of the catheter 3704 and alsoconfigured to prevent kinking and/or bending of the catheter.

The catheter 3728 includes a hub 3732 with a connector 3735. The lumenof the catheter 3728 is configured to deliver a pharmacological agent toa desired treatment situs. The length of the catheter shaft 3730 issized to be shorter than the distal end of the catheter shaft 3710 andshorter than lateral port 3712. Optionally, one or more predeterminedportions of the catheter 3730 can include a visualization enhancement.The visualization enhancement may include an echogenic material arrangedat a predetermined location of the shaft and in a predetermined patternas described herein.

FIG. 37E illustrates a catheter according to another embodiment of theinvention.

Referring to FIG. 37E, a catheter is generally depicted as referencenumber 3734. The catheter 3734 includes a rigid shaft 3736 having alumen extending from proximal end to a distal end and the shaft 3736.The shaft 3736 is coupled to a hub 3738. The catheter 3734 includeslateral ports 3740. The catheter 3734 is also sized to be inserted intoa lumen of the catheter 3704, thereby strengthening the shaft 3710 ofthe catheter 3704 and substantially preventing kinking and/or bending ofthe catheter 3704.

The catheter shaft 3736 includes a hub 3738 with a fitting 3737. Thelumen of the catheter 3734 is configured to deliver a pharmacologicalagent to a desired treatment situs when in use. The length of thecatheter shaft 3736 is sized to be longer than the distal end of thecatheter 3704. In a preferred embodiment, the length of the catheter3734 is sized such that the lateral ports 3740 extend immediately outthe distal end of the catheter 3704. A distal end of the catheter 3734can include a visualization enhancement at a desired location. Thevisualization enhancement may include an echogenic material arranged ata predetermined location of the shaft and predetermined pattern asdescribed herein.

FIG. 37F illustrates a catheter according to another embodiment of theinvention.

Referring to FIG. 37F, a catheter is generally depicted as referencenumber 3742. The catheter 3742 includes a rigid shaft 3746 having alumen extending from proximal end to a distal end of the shaft 3746. Theshaft 3746 is coupled to a hub 3743. The catheter 3742 includes lateralports 3748 and is sized to be inserted into a lumen of the catheter3704, thereby strengthening the shaft 3710 of the catheter 3705 andsubstantially preventing kinking and/or bending of the shaft 3710.

The catheter 3742 includes a hub 3743 with a fitting 3739. The lumen ofthe catheter 3742 is configured to deliver a pharmacological agent to adesired treatment situs. The length of the catheter shaft 3746 is sizedto be longer than the distal end of the catheter 3704. In a preferredembodiment, the length of the catheter 3742 is sized such that lateralports 3748 extend immediately out a distal end of the catheter 3704. Adistal end of the catheter 3742 can include a visualization enhancementmaterial at a desired location. The visualization enhancement materialmay include an echogenic material arranged at a predetermined locationof the shaft and arranged in predetermined patterns. The distal end ofthe catheter 3742 includes preformed curvature as described herein.

FIG. 37G illustrates a catheter according to another embodiment of theinvention.

Referring to FIG. 37G, a catheter is generally depicted as referencenumber 3750. The catheter 3750 includes a rigid shaft 3752 having alumen extending from proximal end to a distal end of the shaft 3752. Theshaft 3752 is coupled to a hub 3753. The catheter 3750 includes lateralports 3754 and is sized to be inserted into a lumen of the catheter3704, thereby strengthening the shaft 3710 of the catheter 3704 tosubstantially prevent kinking and/or bending of the shaft 3710.

The catheter 3750 includes a hub 3753 including a fitting 3741. The hub3753 also includes a conductive element 3745. The conductive element3745 is formed from a single mold unit as described herein. A conductivewire or element not shown extends down a catheter shaft 3752 asdescribed herein with reference to FIG. 3B. The catheter 3750 includes aconductive end portion, e.g. cap. The catheter is used as a stimulatingcatheter configured to stimulate a nerve and extend out a distal end ofthe catheter 3704.

The length of the catheter shaft 3752 is sized to be longer than thedistal end of the catheter 3704. In a preferred embodiment, the lengthof the catheter 3750 is sized such that the lateral ports 3756 extendimmediately out the distal end of the catheter 3742. Optionally, adistal end portion of the catheter 3742 can include a visualizationenhancement material at a desired location. The visualizationenhancement material may include an echogenic material arranged at apredetermined location of the shaft and predetermined pattern asdescribed herein. The distal end of the catheter may also includepreformed curvature as described herein.

FIG. 38 illustrates a medical device kit according to another embodimentof the invention.

Referring to FIG. 38, a kit is generally depicted as reference number3800. The kit 3800 is configured to hold an apparatus and associatedmedical surgical items described herein. In this embodiment, the kit3800 includes a thermo formed mold constructed from a thermoplasticmaterial. The mold has a plurality of recessed slots to receive variouscomponents of the kit. The kit and the components are sterilized tocomply with governmental medical standards, e.g., U.S. Food and DrugAdministration (FDA) standards. A protective sterile plastic film coversand seals the kit.

The kit 3800 includes a first needle 3802 having first size, a secondneedle 3804 having a second size smaller than the size of the firstneedle, a first syringe 3806, a label (not shown), a steri-strip 3810, ategaderm patch 3812, a filter 3814, an electrical connector 3816, asecond syringe 3818 smaller than the size of the first syringe 3806, anextension set 3820 as described with reference to FIGS. 35A-35B, and anapparatus and cannula described according to any of the embodimentsherein.

Described next is a method of administrating a pharmacological agent inaccordance with another embodiment of the invention. This embodimentwill be described with reference to the continuous anesthesia nerveconduction apparatus described herein FIGS. 3A-3C. However, anyapparatus described herein may be used with this procedure.

Advantageously, the method of administering the pharmacological agent inaccordance with the invention does not need to occur in a fully sterileenvironment and is much faster than the traditional methods ofadministrating a pharmacological agent. In addition, the operator canperform the method by herself without requiring assistance from anotherperson.

Initially, preparatory steps are performed prior to performing aprocedure. These steps include applying non-sterile gloves on both handsand opening sterile packaging kit 3800 of the apparatus 302. Next, acannula 304 is positioned through the lumen 326 of the catheter 302, andthe cannula 304 is secured to the hub of the catheter 302 via lockingmechanism 322. In an embodiment, each of the items used during theprocedure are provided in a sterile kit. In another embodiment, eachitem used during the procedure is preassembled in the kit.

A syringe (not shown) is connected to the cannula hub 320. A distalportion of the catheter 302 is maintained in a sterile manner within itscovering. The proximal portion of the catheter 302 and cannula 304 areexposed so that a standard syringe filled with a liquid solution iscoupled to the hub 320.

Next, a patient is positioned according to the type and location ofnerve(s) to be targeted as known in the art. The operative portion ofthe patient (insertion site) is prepped with an antiseptic solution. Ifa peripheral nerve stimulator is being used, the peripheral nervestimulator is connected to the exposed proximal end of the apparatus viaan electrode connector 316 on the proximal hub of the catheter 302. Thenecessary connection for the peripheral nerve stimulator to the patientis also performed and the nerve stimulator is activated for theappropriate setting as known in the art.

An ultrasound probe is held in the non-operative hand and positioned onthe patient to obtain an image of the targeted nerve(s). Once theultrasound probe is in position, the insertion site for the apparatusincluding a cannula 304 and catheter 302 (combined apparatus) can beascertained and a skin wheal is raised to anesthetize the insertionsite.

With the other hand (operative hand), the combined apparatus is slippedout of the sterile covering and inserted through the insertion site. Thedistal tip of the combined apparatus is then advanced towards thetargeted nerve(s) under direct visualization via the ultrasound image.

If nerve stimulation is used, the distal tip of the combined apparatusis advanced towards the targeted nerve(s) until the appropriate musclestimulation is obtained for confirmation that the distal tip of theapparatus is positioned in proximity to the targeted nerve(s). Onceadjacent to the targeted nerve(s), the solution in the standard syringethat was previously attached to the proximal hub of the introducingcannula 304 is injected to hydro-dissect the tissue surrounding thetargeted nerve(s). Real time ultrasound visualization is possiblebecause the non-operative hand is simultaneously positioning theultrasound probe to obtain a view of the targeted nerve(s) and whilepositioning the distal portion of the inserted apparatus with theoperative hand.

Once the tissue surrounding the nerve(s) is expanded with the solutionin the syringe, the proximal hub 306 of the catheter is released fromthe hub lock 322 on the proximal hub 320 of the introducing cannula 304with the operative hand. The catheter 302 is then advanced with a fingerof the operative hand while the introducing cannula 304 is withdrawnfrom the lumen of the catheter 302 with the operative hand, much likeadvancing an intravenous catheter off the needle and into a bloodvessel. This is done simultaneously while maintaining an ultrasoundimage of the distal portion of the catheter 302 and the targetednerve(s) with the non-operative hand manipulating/managing theultrasound probe. If the catheter's distal tip is not able to extendinto its preformed shape due to tissue obstruction, a guidewire can bepositioned through the lumen of the cannula to aid the directionalpositioning of the catheter tip.

With the catheter 302 positioned adjacent to the targeted nerve(s), andthe introducing cannula 304 withdrawn, another syringe with localanesthetic solution is connected to the proximal hub of the catheterthat is exteriorized on the patient, and local anesthetic can beinjected via the catheter alone, while again being visualized inreal-time with the ultrasound imaging maintained by the non-operativehand. Once placement of the distal tip of the catheter 302 and localanesthetic spread is confirmed by ultrasound imaging, the ultrasoundprobe and/or the peripheral nerve stimulator can be set aside.

The syringe can then be disconnected from the catheter 302, and theproximal hub 306 of the catheter 302 is secured to the patient's skinwith adhesive tape applied to the hub and wings 308, 310. The hub canthen be capped or connected to an infusion pump via a connecting tube.The externalized portion of the catheter 302 and hub 306 can be coveredwith a clear dressing to further minimize dislodgement, and maintainsterility.

These steps can be accomplished by one proficient in the arts inapproximately the same time or less than it takes to perform asingle-injection nerve block with a needle alone. The approximate timefrom positioning the patient (according to the type and location ofnerve(s) to be targeted as known in the art) to securing and dressingthe hub can take less than 10 minutes. In a preferred embodiment, theprocedure takes less than 10 minutes to perform.

Another embodiment of the invention includes a kit for the delivery of afluid to a nerve bundle of a patient. The kit includes a pump, a lengthof tubing securable to said pump, an introducer, and a catheter. Theintroducer is configured to fit within the catheter. The pump, tubing,catheter and introducer are provided together as a kit. Other items mayalso be provided in the kit, e.g., guidewire and stimulator.

Without intending to limit the scope of the invention, the followingexamples illustrate how various embodiments of the invention may be madeand/or used.

EXAMPLES

The following examples illustrate the time to insert a catheter, securethe catheter and dress the patient using the method described herein(Example 1) as compared to the traditional method (Example 2).

Table 1 illustrates a timed comparison between the steps and methodduration of Example 1, the method described herein, and steps and methodduration of Example 2, the traditional method. Each step is described indetail below. All time listed in Table 1 are approximate.

Example 1

Examples 1 and 2 are directed towards a medical procedure for insertinga catheter for delivering a pharmacological agent to a nerve bundle inthe neck of a patient. The method in each example generally includedthree broad steps: Step 1—Setup; Step 2—Procedure; and Step 3—SecuringCatheter. Example 1 was conducted with an apparatus according toembodiments of the invention. Example 2 was conducted with a needle overcatheter apparatus and the procedure to insert the needle over catheterapparatus.

Step 1: (Setup): The operator opened a single sterile device package,which included supplies such as a Terumo® 2.5 inch 18 gauge Surflo® I.V.Catheter. FIG. 39 illustrates items used in the procedure of Example 1.With reference to FIG. 39, these items include (starting from the topleft of FIG. 39 and proceeding counter-clockwise) tubing (white packagepartially open) 3902, 5 cc syringe 3904 containing medication to sedatethe patient, 3 cc syringe 3906 with a 25 gauge 1.5 inch needle attachedto the syringe which contained Lidocaine, a 20 cc syringe 3908 withRopivicaine, another 20 cc syringe 3910 which contained Ropivicaine withan angiocath attached to the syringe within a cover (the angiocath is an18 gauge 2.5 inch needle within an 18 gauge 2.5 inch catheter, where theneedle extends just past the tip of the catheter), a package of Betadineswabs 3912, securing strips 3914, a tacky substance 3916 to attach thesecuring strips and a clear dressing 3918. The operator put onnon-sterile gloves and filled the syringes. The local area on thepatient where the angiocath was inserted was prepared by swabbing thearea with Betadine as illustrated in FIG. 40. The operator put theultrasound probe in the vicinity of the nerve bundle. The ultrasoundprobe contained a small amount of gel applied to the tip of the probe.The probe was used to monitor the area surrounding the nerve bundlethroughout the procedure.

Step 2: (Procedure): The operator obtained an ultrasound image of thearea, and then anesthetized the skin and subcutaneous area with the 3 ccsyringe filled with Lidocaine as illustrated in FIG. 41. The 1.5 inchneedle attached to the 3 cc syringe extended to the nerve bundle, whichwas monitored using the ultrasound image. The 1.5 inch needle waswithdrawn from the patient and set aside. The operator picked up the 20cc syringe of Ropivicaine with the angiocath attached and slipped offthe housing. The operator inserted the angiocath into the patent anddirected the angiocath to the nerve bundle using the needle of theangiocath until the angiocath was near the nerve bundle, which wasmonitored using an ultrasound image as illustrated in FIG. 42. Once theoperator reached the nerve bundle, the operator hydrodissected thetissue surrounding the nerve bundle using the Ropivicaine in the 20 ccsyringe while monitoring the tissue surrounding the nerve bundle with anultrasound image as illustrated in FIG. 43. The operator put theirfinger on the tip of the catheter hub and removed the needle while thecatheter was advanced. The needle, which was connected to the syringe,was removed from the catheter with one hand, while the position of thecatheter was monitored using an ultrasound image as illustrated in FIG.44. The operator set down the empty 20 cc syringe, which was stillattached to the needle, and picked up the second 20 cc syringe whichcontained Ropivicaine and connected the syringe to the catheter hub andinjected about 20 cc of Ropivicaine into the patient through thecatheter as illustrated in FIG. 45. This injection of Ropivicaineverified the catheter position and effectiveness. The operator removedand set aside the second syringe from the catheter hub and removed andset aside the ultrasound probe. The operator attached the tubing to thecatheter hub as illustrated in FIG. 46.

Step 3: (Securing the Catheter): The catheter and tubing were secured tothe patient with adhesive strips with the tacky substance and cleardressing was applied as illustrated in FIG. 47.

Comparative Example 2

Step 1: (Setup): The operator opened the package that contained an ArrowStimuCath® Continuous Nerve Block Procedure Kit. The kit was doublewrapped. The operator put on sterile gloves and filled the syringes. Theoperator set up the ultrasound probe and filled the sterile sleeve withgel. The operator placed the probe into the sterile sleeve and securedthe sleeve to the ultrasound probe. The operator attached the PNS. Theoperator draped the patient and prepared a large area surrounding theinjection site.

Step 2: (Procedure): The operator obtained an ultrasound image of thearea, and anesthetized the skin and subcutaneous. The operator insertedthe needle into the patient and hydro-dissected the surrounding tissue.The operator then blindly advanced the catheter through the needle withboth hands, while trying to maintain stimulation of the nerve andadvance the catheter. As the needle was backed out from its position inthe patient, the catheter was advanced. Once the operator believed thecatheter was in place, the operator took another scan of the area withthe ultrasound probe, which was put aside in order to advance thecatheter. Before the operator injected a pharmacological agent throughthe catheter, the operator attached a connector hub to the catheter.After the hub was attached, the tubing was attached.

Step 3: (Securing Catheter): Excess length of the catheter was coiledand the catheter was secured to the patient using adhesive strips. Cleardressing was applied to the patient.

TABLE 1 Comparison Table of Example 1 and Comparison Example 2 Terumo ®2.5 inch Arrow StimuCath ® 18 gauge Continuous Nerve Device Surflo ® I.V. Catheter Block Procedural Kit Step 1 Setup: Opening of packaging00:05 01:00 and supplies Single sterile device Double wrapped in packagesterile kit Gloving 00:10 01:00 Non-sterile gloves Sterile glovesFilling Syringes 00:30 00:30 Drawing up syringes Drawing up syringesfrom kit US Probe setup 00:05 02:30 Apply non- Fill sterile sleeve withgel sterile gel Place probe into sterile sleeve Secure sleeve to probeAttach PNS n/a 00:30 Prep and Drape 00:05 01:00 Betadine swabs- Widesterile prep with no draping sterile draping Step 2 Procedure: Obtainingfirst US image 00:30 00:30 Anesthetize skin and SQ 00:15 00:15 Insertionof needle and 00:15 00:15 catheter system Hyrodissecting of 00:30-02:0000:30-02:00 surrounding tissue (variable) (variable) Positioningcatheter 00:05 01:00-10:00 (variable) Catheter advanced Blindadvancement of off of needle catheter through needle with both handsTrying to maintain stimulation while advancing catheter Removal ofneedle n/a 00:30 Needle withdrawn when Needle is backed out whilecatheter was positioned advancing catheter Rescan for image n/a 00:30 USimage maintain Need to rescan since probe at all times was put aside toadvance catheter Inject through catheter 00:30 01:00 Large bore withNeed to attach connector hub low resistance Long catheter with highresistance Attach tubing to catheter 00:15 00:30 Tubing connecteddirectly Need to attach hub and to catheter hub connect tubing Step 3Securing Catheter: Secure catheter and 00:15 00:30 apply dressingAdhesive strips and Coiling extra catheter length clear dressingAdhesive strips and clear dressing Total time (minutes) 03:30-05:3012:00-24:00

Important distinctions exist between Example 1 and Example 2. Notably,Example 1 is performed by a single clinician. Example 2 requires anassistant simply due to the fact that the operator, equipment andsupplies must maintain sterility with the traditional method.Furthermore, the setup and method explained in Example 2 requires thatall necessary equipment and supplies are handled in a sterile fashion.If any aspect of the method is accidently contaminated, a sterilereplacement for the equipment and supplies will be required, whichfrequently necessitates a new set up.

The steps illustrated in Example 1 are more precise and easily performedby an operator. Example 1 does not require draping or preparation of alarge area on the patient, rather no draping is required and only asmall portion of the patient is prepared. Furthermore, the ultrasoundimager is maintained throughout the procedure in Example 1 as opposed toExample 2. The operator in Example 2 only regains the ultrasound imageof the patient after the needle has been removed. Positioning thecatheter as illustrated in Example 2 is highly variable with regard totime. It is rare that the catheter is in the correct position on thefirst attempt. More typically, the catheter and quite often the needlerequire repositioning which can take considerable time since real-timeultrasound imaging is not available to the operator. Furthermore, if thecatheter is misplaced, then the operator may have to remove the catheterand start over with a new sterile kit.

Compared to the traditional method (Example 2), the method and devicedescribed herein using a catheter that allows for an internal introducercan result in approximately 70% to 80% savings in time. This estimate isconservative and does not take into consideration the time to repositionthe catheter and needle if required, which is likely using thetraditional method.

The inventions and methods described herein can be viewed as a whole, oras a number of separate inventions, that can be used independently ormixed and matched as desired. All inventions, steps, processes, devices,and methods described herein can be mixed and matched as desired. Allpreviously described features, functions, or inventions described hereinor by reference may be mixed and matched as desired.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the spirit or scope of the invention. Forexample, the cannula has a distal end that may include a sharp tip, ashort beveled tip, and/or a Touhy tip. Thus, it is intended that thepresent invention cover all of the modifications and variations of thisinvention provided they come within the scope of the appended claims andtheir equivalents.

1.-194. (canceled)
 195. An over-the-needle catheter assembly,comprising: a catheter comprising a body, said body comprising aproximal end and a distal end, said body defining a lumen extending fromsaid proximal end to said distal end; a conductive coil-shaped insertconfigured within said lumen of said body of said catheter, saidcoil-shaped insert comprising a proximal end and a distal end, saidcoil-shaped insert embedded into an interior wall of said body of saidcatheter and defining a hollow passageway extending from said proximalend to said distal end of said body of said catheter; a handle securedat the proximal end of said coil-shaped insert, said handle defining arecess; a needle configured within the hollow passageway of saidcoil-shaped insert, wherein said coil-shaped insert prevents saidcatheter from kinking when said catheter is within a patient; a needlehub secured at a proximal end of said needle, wherein said needle hub issecured within the recess of said handle so as to form a hub assembly,said hub assembly configured to engage a fluid delivery device; and astimulation assembly configured with said coil-shaped insert, saidstimulation assembly configured to provide stimulation to a targetedsite within the patient via the conductive coil-shaped insert.
 196. Theover-the-needle catheter assembly of claim 195, wherein the needle hubfurther comprises a locking mechanism configured to releasably couplethe needle hub to the handle.
 197. The over-the-needle catheter assemblyof claim 196, wherein the locking mechanism comprises a tab portionconfigured to releasable engage the recess of the handle.
 198. Theover-the-needle catheter assembly of claim 195, wherein the needle hubfurther comprises a central protrusion, the handle further comprises anannular recess, and the central protrusion is configured to engage withthe annular recess via a friction coupling to couple the needle hub tothe handle.
 199. The over-the-needle catheter assembly of claim 195,wherein the body of the catheter further defines one or more lateralport, wherein the one or more lateral port is configured to permit aflow of an agent through the one or more lateral port and the one ormore lateral port is located away from the distal end of the body of thecatheter.
 200. The over-the-needle catheter assembly of claim 195,wherein the stimulation assembly is configured to be electricallycoupled to the coil-shaped insert by a stimulation wire.
 201. Theover-the-needle catheter assembly of claim 195, wherein a first diameterof the body at the distal end is less than a second diameter of the bodyat a location between the distal end and the proximal end of the body.202. The over-the-needle catheter assembly of claim 195, wherein a firstportion of the body at the distal end is more flexible than a secondportion of the body that is between the first portion of the body andthe proximal end of the body.
 203. The over-the-needle catheter assemblyof claim 195, wherein the coil-shaped insert comprises a plurality ofwindings and a first density of the windings within the first portion ofthe body is less than a second density of the windings within the secondportion of the body.
 204. An over-the-needle catheter assembly,comprising: a catheter comprising a body, the body comprising a proximalend and a distal end defining a first length, the body defining a lumenextending from the proximal end to the distal end; a needle configuredto fit within at least a portion of said lumen so as to guide saidcatheter within a patient a targeted site; a needle hub secured at aproximal end of said needle; a conductive coil-shaped insert sized tofit within at least a portion of said lumen of said catheter after saidcatheter is placed adjacent to the targeted site and said needle isremoved, wherein said conductive coil-shaped insert prevents saidcatheter from kinking when said catheter is within the patient, saidconductive coil-shaped insert comprising a second length, said secondlength being longer than said first length such that said conductivecoil-shaped insert is configured to extend past said distal end of saidcatheter when inserted therethrough; and a handle secured at theproximal end of said conductive coil-shaped insert, said handle defininga radial recess, wherein said needle hub is secured within the radialrecess of said handle.
 205. The catheter assembly of claim 10, furthercomprising a stimulation assembly coupled with the conductivecoil-shaped insert, said stimulation assembly configured to providestimulation to the targeted site via a wire within the conductivecoil-shaped insert.
 206. The catheter assembly of claim 11, wherein thestimulation assembly is electrically coupled to the conductivecoil-shaped insert by a stimulation wire, wherein the stimulation wireextends through at least one of the needle hub and the handle.
 207. Theover-the-needle catheter assembly of claim 10, wherein the body of thecatheter further defines an opening, the opening is configured to permita flow of an agent through the opening, and the opening is located awayfrom the distal end of the body of the catheter.
 208. Theover-the-needle catheter assembly of claim 10, wherein a tip region ofthe body of the catheter at the distal end is tapered.
 209. Theover-the-needle catheter assembly of claim 10, wherein a first portionof the body at the distal end is more flexible than a second portion ofthe body that is between the first portion of the body and the proximalend of the body.
 210. An over-the-needle catheter assembly, comprising:a catheter comprising a body, the body comprising a proximal end and adistal end, the body defining a lumen extending from the proximal end tothe distal end, wherein the body further comprises a conductivereinforcement member at least partially embedded within an interior wallof the body, the conductive reinforcement member defining a hollowpassageway through the body of the catheter; a handle secured at theproximal end of the body of the catheter; a needle configured to passthrough the hollow passageway of the conductive reinforcement member,wherein the conductive reinforcement member prevents the catheter fromkinking when the catheter is within a patient; a needle hub secured at aproximal end of the needle, wherein the needle hub is configured toreleasably couple to the handle to form a hub assembly, the hub assemblyconfigured to engage a fluid delivery device; and a stimulation assemblyconfigured with the coil-shaped insert, the stimulation assemblyconfigured to provide stimulation to a targeted site within the patientvia the conductive reinforcement member.
 211. The over-the-needlecatheter assembly of claim 16, wherein the needle hub further comprisesa central protrusion, the handle further comprises an annular recess,and the central protrusion is configured to engage with the annularrecess to couple the needle hub to the handle.
 212. The over-the-needlecatheter assembly of claim 16, wherein the body of the catheter furtherdefines an opening located away from the distal end of the body of thecatheter.
 213. The over-the-needle catheter assembly of claim 16,wherein the needle further comprises a plurality of markings.
 214. Theover-the-needle catheter assembly of claim 16, wherein a first portionof the body at the distal end is more flexible than a second portion ofthe body that is between the first portion of the body and the proximalend of the body.